MIRA 10-K
Mira Pharmaceuticals, Inc. (MIRA)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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MIRA Pharmaceuticals, Inc.
Annual Report on Form 10-K
For the fiscal year ended December 31, 2025
TABLE OF CONTENTS
Unless we have indicated otherwise, or the context otherwise requires, references in this Report to “MIRA,” the “Company,” “we,” “us” and “our” or similar terms refer to MIRA Pharmaceuticals, Inc., a Florida corporation.
From time to time, we may use our website, our Facebook page at https://www.facebook.com/people/MIRA-Pharmaceuticals-Inc/100087641460083, our Twitter at https://twitter.com/PharmaMIRA and on our LinkedIn account at www.linkedin.com/company/mira-pharmaceuticals-inc to distribute material information. Our financial and other material information is routinely posted to and accessible on the Investors section of our website, available at www.mirapharmaceuticals.com. Investors are encouraged to review the Investors section of our website because we may post material information on that site that is not otherwise disseminated by us.
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K (this “Report”) contains forward-looking statements (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act) that reflect our current expectations and views of future events. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential”, or “continue” or the negative of these terms or other similar expressions. In particular, statements about our pre-clinical and clinical trials and expectations regarding such trials, the markets in which we operate, including growth of such markets, and our expectations, beliefs, plans, strategies, objectives, prospects, assumptions, or future events or performance contained in this Report generally under the headings “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business” are forward-looking statements.
We have based these forward-looking statements on our current expectations, assumptions, estimates and projections. While we believe these expectations, assumptions, estimates, and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond our control. These and other important factors, including those discussed in this Report under the headings “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business,” may cause our actual results, performance, or achievements to differ materially from any future results, performance or achievements expressed or implied by these forward-looking statements, or could affect our share price. Important factors that could cause actual results or events to differ materially from those expressed in forward-looking statements include, but are not limited to, the following
| ● | our ability to obtain and maintain regulatory approval of our product candidates; | |
| ● | our ability to contract with third-party suppliers, manufacturers and other service providers and their ability to perform adequately; | |
| ● | the implementation of our business model and strategic plans for our business, product candidates, and technology; | |
| ● | the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; | |
| ● | the initiation, timing, progress and results of our pre-clinical studies and clinical trials, and our research and development programs; | |
| ● | the timing of anticipated regulatory filings; | |
| ● | the timing and availability of data from our clinical trials; | |
| ● | the timing or likelihood of the accomplishment of various scientific, clinical, regulatory, and other product development objectives; | |
| ● | our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals; | |
| ● | our ability to advance product candidates into, and successfully complete, clinical trials; | |
| ● | our ability to recruit and enroll suitable patients in our clinical trials; |
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| ● | our future expenses, capital requirements, need for additional financing, and the period over which we believe that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements; | |
| ● | our ability to obtain additional funding for our operations and development activities; | |
| ● | the accuracy of our estimates regarding expenses, capital requirements and needs for additional financing; | |
| ● | the pricing and reimbursement of our product candidates, if approved; | |
| ● | the rate and degree of market acceptance of our product candidates, if approved; | |
| ● | developments relating to our competitors and our industry; | |
| ● | our ability to successfully commercialize and market our product candidates, if approved; | |
| ● | the potential market size, opportunity, and growth potential for our product candidates if approved. | |
| ● | the development of major public health concerns and the future impact of such concerns on our clinical trials, business operations and funding requirements; and | |
| ● | other risks and factors listed under “Risk Factors” and elsewhere in this Report. |
Given the risks and uncertainties set forth in this Report, you are cautioned not to place undue reliance on such forward-looking statements. The forward-looking statements contained in this Report are not guarantees of future performance and our actual results of operations, financial condition, and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Report. In addition, even if our results of operations, financial condition and liquidity, and events in the industry in which we operate, are consistent with the forward-looking statements contained in this Report, they may not be predictive of results or developments in future periods.
Any forward-looking statement that we make in this Report speaks only as of the date of such statement. Except as required by federal securities laws, we do not undertake any obligation to update or revise, or to publicly announce any update or revision to, any of the forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this Report.
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PART I
ITEM 1. Description of Business
Overview
MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA, the “Company”, “we”, “us”) is a clinical-stage pharmaceutical development company advancing a pipeline of novel oral therapeutics targeting neurologic, neuropsychiatric, metabolic, and addiction-related disorders. The Company holds exclusive rights in the United States, Canada, and Mexico to Ketamir-2, MIRA-55, and SKNY-1, three drug candidates designed to address significant unmet medical needs across neuropathic and inflammatory pain, central nervous system disorders, and metabolic and behavioral conditions.
Ketamir-2 is a next-generation oral NMDA receptor modulator that has completed a Phase 1 clinical trial in healthy volunteers. The study included both single-ascending-dose (SAD) and multiple-ascending-dose (MAD) cohorts, and dosing has been completed across all cohorts. Based on preliminary safety data reviewed to date, no serious adverse events or dose-limiting toxicities have been reported; however, the database remains blinded and final audited safety and pharmacokinetic analyses are ongoing. The Company is preparing to initiate a Phase 2a clinical trial in chemotherapy-induced peripheral neuropathy (CIPN) in the first half of 2026, subject to regulatory feedback and site readiness.
MIRA-55 is a novel oral, non-psychoactive cannabinoid analog under preclinical development for inflammatory pain and central nervous system–related conditions, including anxiety and cognitive impairment. In validated preclinical models, MIRA-55 has demonstrated both analgesic and anti-inflammatory activity, including restoration of pain thresholds and reduction of inflammation in inflammatory pain models. In comparative studies, the compound produced analgesic effects comparable to morphine, while also demonstrating direct anti-inflammatory activity not observed with opioid treatment under the conditions evaluated.
In a series of behavioral and safety assessments, MIRA-55 did not demonstrate cannabinoid-like central nervous system adverse effects, including sedation, catalepsy, or anxiogenic responses, at tested doses in preclinical models. These findings support a differentiated pharmacological profile designed to minimize CB1-mediated effects while maintaining therapeutic activity.
The Company is advancing MIRA-55 through IND-enabling development activities and is targeting an Investigational New Drug (IND) submission for inflammatory pain, subject to completion of required preclinical studies, manufacturing readiness, regulatory interactions, and available capital resources.
The U.S. Drug Enforcement Administration (DEA) has completed its scientific review of Ketamir-2, MIRA-55, and SKNY-1 and concluded that each compound is not currently considered a controlled substance or listed chemical under the Controlled Substances Act (CSA) and applicable regulations.
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On September 29, 2025, MIRA acquired SKNY Pharmaceuticals, Inc., a Delaware corporation (“SKNY”), a private company and related party, developing SKNY-1, a preclinical-stage oral therapeutic candidate designed to modulate CB1 and CB2 receptor signaling and selectively inhibit monoamine oxidase B (MAO-B). SKNY-1 is being developed to target pathways involved in energy balance, lipid metabolism, appetite regulation, reward, and craving-related behaviors.
SKNY-1 has been evaluated in preclinical behavioral and metabolic models. In validated animal models that simulate obesity and reward-driven behavior, oral administration of SKNY-1 was associated with reductions in body weight, food consumption, and nicotine-seeking behavior compared with controls. In these studies, weight reduction was not accompanied by measurable loss of muscle mass under the conditions evaluated. Additional findings demonstrated improvements in metabolic parameters and modulation of craving-related behaviors.
In behavioral assessments, SKNY-1 did not demonstrate anxiety-like or other adverse central nervous system–related behavioral effects in the models studied, and in certain conditions mitigated CB1-related behavioral responses. These observations support a differentiated pharmacological profile relative to prior CB1-targeting agents.
The Company is conducting additional preclinical studies to further characterize SKNY-1 in models of obesity and nicotine dependence and is advancing the program toward IND-enabling development activities. Subject to completion of required studies, manufacturing readiness, regulatory interactions, and available capital resources, the Company is targeting an Investigational New Drug (IND) submission for SKNY-1 in 2026.
Ketamir-2: Selective Oral NMDA Receptor Modulator
Ketamir-2 is a patent-pending, orally bioavailable NMDA receptor modulator being developed for neuropathic pain, with an initial focus on chemotherapy-induced peripheral neuropathy (CIPN). The Company has completed dosing in a Phase 1 clinical trial in healthy volunteers, including both single-ascending-dose (SAD) and multiple-ascending-dose (MAD) cohorts. Database lock, unblinding, and final safety and pharmacokinetic analyses are ongoing.
Ketamir-2 is designed to selectively modulate the NMDA receptor (PCP binding site) with low binding affinity and limited off-target receptor activity, with the goal of improving tolerability relative to ketamine. Subject to regulatory interactions and operational readiness, the Company plans to advance Ketamir-2 into a Phase 2a clinical trial in CIPN in the first half of 2026.
MIRA-55: Oral Cannabinoid Analog
MIRA-55 is a novel oral cannabinoid analog in preclinical development for inflammatory pain and central nervous system–related conditions, including anxiety and cognitive impairment. The compound has been designed to preferentially modulate CB2 receptor activity while minimizing CB1-mediated central nervous system effects.
In preclinical models, MIRA-55 has demonstrated analgesic and anti-inflammatory activity, including restoration of pain thresholds and reduction of inflammation in inflammatory pain models. In behavioral assessments, the compound did not demonstrate cannabinoid-like central nervous system adverse effects under the conditions evaluated. The Company is advancing MIRA-55 through IND-enabling development activities and is targeting an IND submission for inflammatory pain, subject to completion of required studies and regulatory interactions.
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SKNY-1: Oral Therapeutic Candidate for Metabolic and Addiction-Related Indications
SKNY-1 is a preclinical-stage oral therapeutic candidate designed to modulate CB1 and CB2 receptor signaling and selectively inhibit monoamine oxidase B (MAO-B). The compound is being developed to target pathways involved in energy balance, appetite regulation, reward, and craving-related behaviors, with initial focus on weight management and nicotine dependence.
In preclinical metabolic and behavioral models, SKNY-1 has demonstrated reductions in body weight, food intake, and nicotine-seeking behavior. In these studies, weight reduction was not associated with measurable loss of muscle mass under the conditions evaluated. Behavioral assessments did not demonstrate adverse central nervous system–related effects in the models studied. The Company is conducting additional preclinical studies and is advancing SKNY-1 toward IND-enabling development activities, with a targeted IND submission in 2026, subject to completion of required studies and regulatory interactions.
Regulatory and DEA Classification
The U.S. Drug Enforcement Administration (DEA) has completed its scientific review of Ketamir-2, MIRA-55, and SKNY-1 and concluded that each compound is not currently considered a controlled substance or listed chemical under the Controlled Substances Act (CSA) and applicable regulations. This regulatory distinction may facilitate clinical development and commercialization by avoiding certain regulatory requirements applicable to controlled substances.
Preclinical Studies and Pharmacology of Ketamir-2
We have conducted preclinical studies to characterize the pharmacological profile, safety, and therapeutic potential of Ketamir-2, an investigational compound targeting neuropathic pain and related conditions. These studies include in vitro and in vivo assessments evaluating receptor binding, efficacy, selectivity, pharmacokinetics, metabolism, general pharmacology, and toxicology.
Mechanism of Action and Receptor Selectivity
Ketamir-2 has been identified as a low-affinity NMDA receptor antagonist that selectively binds to the phencyclidine (PCP) site, with an IC50 of approximately 100 µM. Its primary metabolite, nor-Ketamir-2, also interacts with the PCP site and does not exhibit meaningful affinity for other receptor systems evaluated. This targeted receptor interaction differentiates Ketamir-2 from ketamine, which exhibits broader receptor binding, including opioid and monoaminergic receptors, and binds to NMDA receptors with significantly higher affinity.
Efficacy in Animal Models
The pharmacological activity of Ketamir-2 has been evaluated in preclinical neuropathic pain and behavioral models. In neuropathic pain models, including the Chung model, treatment with Ketamir-2 was associated with improvements in pain thresholds at multiple dose levels. In behavioral assessments, including the open-field test, elevated plus maze, and forced swim test, Ketamir-2 demonstrated activity consistent with modulation of anxiety- and depression-related pathways.
These effects were observed without evidence of significant off-target receptor activity in the models evaluated. Preclinical findings may not be predictive of clinical outcomes.
Phase 1 Clinical Evaluation
Ketamir-2 has been evaluated in a randomized, double-blind, placebo-controlled Phase 1 clinical trial in healthy volunteers, including both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. Dosing has been completed across all cohorts, and database lock and final analyses are ongoing.
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Based on safety data reviewed to date, Ketamir-2 has been observed to be generally well tolerated at the dose levels evaluated, with no serious adverse events or dose-limiting toxicities reported. No clinically significant dissociative or psychotomimetic effects typically associated with ketamine were observed.
These observations are preliminary, and final safety, tolerability, and pharmacokinetic results remain subject to completion of data analysis.
Preclinical Studies and Pharmacology of MIRA-55
We have conducted preclinical studies to evaluate the pharmacological activity of MIRA-55, a cannabinoid analog under development for inflammatory pain and central nervous system–related conditions. These studies include receptor-binding assays, behavioral models, and inflammatory pain models.
In preclinical models, MIRA-55 demonstrated activity consistent with modulation of inflammatory pathways and pain responses, including reductions in inflammation and normalization of pain thresholds in validated inflammatory pain models. In comparative studies, MIRA-55 demonstrated analgesic activity in these models without evidence of opioid-like or cannabinoid-like central nervous system adverse effects under the conditions evaluated.
These findings are based on preclinical studies, and their relevance to human clinical outcomes has not been established.
Preclinical Studies and Pharmacology of SKNY-1
We have conducted preclinical studies to evaluate the pharmacological activity of SKNY-1, a therapeutic candidate targeting metabolic and addiction-related pathways, including appetite regulation and reward-driven behaviors.
In preclinical models, including zebrafish models designed to assess obesity and craving-related behaviors, SKNY-1 administration was associated with reductions in food intake, body weight, and nicotine-seeking behavior. In these studies, weight reduction was not associated with measurable loss of muscle mass under the conditions evaluated. Additional observations included changes in metabolic parameters and behavioral responses associated with reward and craving.
Preclinical behavioral assessments did not demonstrate adverse central nervous system–related effects in the models studied.
These findings are based on preclinical studies, and their relevance to human clinical outcomes has not been established.
Recent Developments
Completion of Phase 1 Clinical Trial of Ketamir-2
In March 2026, the Company announced the completion of dosing in its Phase 1 clinical trial evaluating Ketamir-2, a proprietary oral NMDA receptor modulator, in healthy volunteers. The randomized, double-blind, placebo-controlled study included both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts.
A total of 56 participants were enrolled across all cohorts. Based on safety data reviewed to date, no serious adverse events or dose-limiting toxicities have been reported at any dose level tested. In addition, no clinically significant dissociative or psychotomimetic effects typically associated with ketamine were observed.
Database lock, unblinding, and final pharmacokinetic and safety analyses are ongoing.
Grant of Bonus Cash and RSUs
On March 29, 2026, the Board and the Compensation Committee of the Board determined the certain milestone in Company’s Phase I clinical trial had been achieved. As a result, on March 29, 2026, the grant date, the Company issued Erez Aminov $80,753 in cash and 83,500 vested restricted stock units, with the restricted stock units having an aggregate fair market value of approximately $86,000.
Resignation as Director Candidate
On March 30, 2026, Kelly Stackpole informed the Company that he will not be joining the Board in the future, as was originally disclosed in connection with the Company’s acquisition of SKNY.
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Planned Phase 2a Study in Chemotherapy-Induced Peripheral Neuropathy (CIPN)
The Company intends to advance Ketamir-2 into a Phase 2a clinical study in patients with chemotherapy-induced peripheral neuropathy (CIPN) under its active Investigational New Drug (IND) application. Submission of the Phase 2a protocol and supporting documentation to the U.S. Food and Drug Administration (FDA) is expected in the first half of 2026, subject to regulatory review and site readiness.
Ketamir-2 Clinical Development Strategy
Ketamir-2 is being advanced through a staged clinical development program focused on evaluating safety, pharmacokinetics, and clinical efficacy in neuropathic pain indications.
The Company has completed a Phase 1 clinical trial of Ketamir-2 in healthy volunteers, including both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. Final data analysis is ongoing.
Following completion of Phase 1, the Company is preparing to initiate a Phase 2a proof-of-concept study in patients with chemotherapy-induced peripheral neuropathy (CIPN) under its active Investigational New Drug (IND) application.
The planned Phase 2a study is expected to evaluate safety, tolerability, and preliminary efficacy using validated neuropathic pain endpoints. The Company’s objective is to generate data to support further clinical development and potential regulatory advancement.
Future development activities may include additional studies in neuropathic pain and other central nervous system–related indications, subject to regulatory feedback and available resources.
Compensation Award to Chief Executive Officer
On March 26, 2026, following the successful completion of the Phase 1 clinical trial for Ketamir-2, the Compensation Committee of the Board of Directors approved certain performance-based compensation awards to the Company’s Chief Executive Officer, Erez Aminov, in accordance with the Company’s 2023 Equity Incentive Plan and Short-Term Incentive program.
In connection with the achievement of this clinical milestone:
| ● | The Company granted 83,500 restricted stock units (RSUs), representing a performance-based equity award tied to the completion of the Ketamir-2 Phase 1 clinical milestone; and | |
| ● | The Company approved a short-term incentive (STI) cash bonus of $80,753, representing the target payout associated with clinical milestone achievement under the Company’s executive compensation framework. |
These awards were granted pursuant to the Company’s previously established compensation structure, which aligns executive incentives with key clinical and strategic milestones .
Regulatory Status and Development Progress
Ketamir-2 has completed a Phase 1 clinical trial in healthy volunteers under an active Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA). Final data analysis is ongoing. The Company is preparing to advance Ketamir-2 into a Phase 2a clinical study in patients with chemotherapy-induced peripheral neuropathy (CIPN), subject to regulatory review.
MIRA-55 and SKNY-1 are currently in preclinical development. The Company is preparing to initiate IND-enabling activities, including toxicology, safety pharmacology, and manufacturing development, in support of potential future IND submissions. The timing of such activities and submissions will depend on regulatory interactions, development progress, and available resources.
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Clinical Development of Ketamir-2
Ketamir-2 has been evaluated in a randomized, double-blind, placebo-controlled Phase 1 clinical trial in healthy volunteers, including both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. Dosing has been completed across all cohorts, and final data analysis is ongoing.
Based on safety data reviewed to date, Ketamir-2 has been observed to be generally well tolerated at the dose levels evaluated, with no serious adverse events or dose-limiting toxicities reported. No clinically significant dissociative or psychotomimetic effects typically associated with ketamine were observed.
The Company is preparing to initiate a Phase 2a clinical study in patients with chemotherapy-induced peripheral neuropathy (CIPN) under its active Investigational New Drug (IND) application. The planned study is expected to evaluate safety, tolerability, and preliminary efficacy using validated neuropathic pain endpoints.
Clinical Manufacturing and Supply
Recipharm Israel Ltd., a contract development and manufacturing organization (CDMO), has completed development and GMP manufacturing of Ketamir-2 for use in preclinical and clinical studies.
Preclinical Development of Mira-55
The Company has conducted a series of in vitro and in vivo preclinical studies to characterize the pharmacological activity of MIRA-55.
Receptor Pharmacology
Radio-ligand binding and functional assays have demonstrated preferential CB2 receptor activity relative to CB1 receptors, consistent with the compound’s design to limit CB1-mediated psychoactive effects.
Pain and Inflammatory Models
MIRA-55 has been evaluated in validated models of inflammatory and nociceptive pain. In a formalin-induced inflammatory pain model, oral administration of MIRA-55 restored pain thresholds to baseline levels and significantly reduced inflammation as measured by paw edema. In these studies, MIRA-55 demonstrated greater normalization of pain responses compared to morphine, which primarily affects central pain perception without directly addressing inflammation.
Behavioral and Anxiety Models
MIRA-55 has been evaluated in the Elevated Plus Maze (EPM), a validated rodent model of anxiety-related behavior. In these studies, MIRA-55-treated animals demonstrated increased time spent in open arms compared to controls, consistent with reduced anxiety-like behavior, without evidence of sedation or locomotor impairment.
Central Nervous System Safety Profile
Across a range of validated behavioral assays, including hypothermia, catalepsy, open field, and EPM testing, MIRA-55 did not demonstrate cannabinoid-like central nervous system side effects typically associated with CB1 receptor activation. No evidence of sedation, motor impairment, or anxiogenic effects was observed in preclinical studies.
Preclinical results may not be predictive of clinical outcomes.
SKNY-1 Preclinical Development
The Company has conducted a series of preclinical studies to evaluate the pharmacological activity and therapeutic potential of SKNY-1 in models of metabolic regulation, appetite, and reward-driven behavior.
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Metabolic and Weight Loss Models
SKNY-1 has been evaluated in validated zebrafish models of obesity and metabolic dysfunction. In these studies, oral administration of SKNY-1 resulted in significant reductions in body weight, with treated animals demonstrating up to approximately 30% weight loss over the study period. Importantly, weight reduction was achieved without evidence of muscle loss, suggesting preservation of lean body mass.
In addition, SKNY-1 treatment was associated with normalization of metabolic parameters, including reductions in liver fat accumulation and improvements in lipid profiles, supporting its potential role in metabolic regulation.
Appetite and Behavioral Models
In preclinical models assessing feeding behavior and compulsivity, SKNY-1 demonstrated dose-dependent reductions in high-calorie food consumption and decreased food-seeking behavior under stress conditions. Treated animals showed reduced compulsive feeding patterns and improved regulation of appetite-related behaviors.
Nicotine and Reward Models
SKNY-1 has also been evaluated in models of nicotine-seeking behavior. In these studies, treatment with SKNY-1 reduced nicotine preference and decreased reward-seeking behavior associated with nicotine exposure. Behavioral responses in treated animals approached those observed in non-dependent control groups, suggesting potential activity in addiction-related pathways.
Neurobehavioral and CNS Safety Profile
In validated behavioral models assessing anxiety-related responses, SKNY-1 demonstrated reversal of CB1 agonist-induced anxiety-like behavior and did not exhibit the adverse neuropsychiatric effects associated with earlier CB1-targeting compounds. These findings support a differentiated central nervous system profile relative to prior therapies in this class.
Hormonal and Neurochemical Effects
Preclinical studies have shown that SKNY-1 modulates key metabolic and neurohormonal markers associated with appetite and reward, including normalization of leptin and ghrelin levels and modulation of dopamine signaling pathways. These findings are consistent with the compound’s proposed mechanism targeting appetite regulation and reward processing.
Preclinical results may not be predictive of clinical outcomes.
Market Opportunity and Competitive Positioning
Ketamir-2 – Neuropathic Pain
Neuropathic pain is a significant and growing health concern in the United States, affecting an estimated 7–10% of adults based on published epidemiological data. According to third-party market research, the North American neuropathic pain market is estimated in the multi-billion-dollar range and is expected to grow significantly over the remainder of the decade, driven by an aging population, increasing prevalence of diabetes, chemotherapy-induced peripheral neuropathy (CIPN), and post-surgical nerve injuries.
There are currently no therapies approved by the U.S. Food and Drug Administration specifically for CIPN, and treatment is typically limited to off-label use of antidepressants, anticonvulsants, and opioids. These therapies often provide incomplete pain relief and may be associated with tolerability and safety concerns, including sedation, cognitive impairment, and risk of dependence.
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Ketamir-2 is designed as an oral NMDA receptor modulator with a differentiated safety and tolerability profile relative to ketamine, including the absence of clinically significant dissociative effects observed to date. The Company believes Ketamir-2 may offer advantages including oral administration, reduced abuse potential, and improved tolerability, positioning it as a potential alternative to existing therapies.
MIRA-55 – Inflammatory Pain
Chronic inflammatory pain represents a large and underserved global market, historically dominated by opioids and nonsteroidal anti-inflammatory drugs (NSAIDs), both of which are associated with significant safety limitations, including risk of dependence, gastrointestinal toxicity, and cardiovascular adverse effects.
According to third-party market research, the global non-opioid pain treatment market represents a large and growing commercial opportunity, with continued demand for safer and more effective alternatives to existing therapies.
MIRA-55 is designed to address both inflammation and pain through preferential CB2 receptor activity, with preclinical data demonstrating dual anti-inflammatory and analgesic effects without evidence of cannabinoid-related central nervous system side effects. The Company believes this differentiated pharmacological profile may position MIRA-55 as a potential non-opioid alternative in the treatment of inflammatory pain.
SKNY-1 – Obesity and Nicotine Addiction
Obesity and nicotine addiction are among the leading causes of preventable death globally and represent large and rapidly growing therapeutic markets.
According to third-party market research and industry analyses, the global obesity therapeutics market is projected to exceed $100 billion over the next decade and may reach significantly higher levels as demand for effective and accessible treatments continues to increase. Current therapies, including GLP-1 receptor agonists, are associated with limitations such as injectable administration, gastrointestinal side effects, and loss of lean muscle mass.
The global smoking cessation market is also substantial and is expected to continue to grow, although existing therapies are associated with modest long-term success rates and, in some cases, neuropsychiatric safety concerns.
SKNY-1 is a differentiated oral therapeutic designed to modulate CB1, CB2, and MAO-B pathways involved in appetite, reward, and metabolic regulation. In preclinical studies, SKNY-1 demonstrated significant weight loss without evidence of muscle loss, reduction in high-calorie food consumption, and reversal of nicotine-seeking behavior, along with a favorable central nervous system safety profile relative to prior CB1-targeting agents.
The Company believes SKNY-1’s oral administration, multi-target mechanism, and dual indication potential may position it as a differentiated candidate across both obesity and addiction markets.
Development Strategy
Our development strategy is focused on advancing a diversified pipeline of differentiated small-molecule therapeutics targeting neurological, neuropsychiatric, inflammatory, and metabolic disorders. We aim to generate clinically meaningful data, pursue efficient regulatory pathways, and maximize long-term value through a combination of internal development and strategic collaborations.
Ketamir-2
For Ketamir-2, our strategy is to advance clinical development in neuropathic pain, with an initial focus on chemotherapy-induced peripheral neuropathy (CIPN), a condition with significant unmet medical need and no FDA-approved therapies.
We have completed Phase 1 clinical development, including both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, and are advancing toward a Phase 2a proof-of-concept study. Our objective is to generate clinical data demonstrating safety, tolerability, and preliminary efficacy in patients.
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In parallel, we intend to evaluate additional indications where NMDA receptor modulation may have therapeutic relevance, including neuropsychiatric disorders. We also plan to explore strategic partnerships to support later-stage development and potential commercialization.
MIRA-55
For MIRA-55, our strategy is to advance a differentiated cannabinoid-based therapeutic targeting inflammatory pain and related conditions.
MIRA-55 is currently progressing through IND-enabling studies, including safety pharmacology, toxicology, and manufacturing scale-up activities. Our objective is to support a potential Investigational New Drug (IND) submission and initiate clinical evaluation, subject to completion of required studies and regulatory interactions.
We plan to focus initial development on inflammatory pain indications, based on preclinical data demonstrating dual anti-inflammatory and analgesic effects without evidence of cannabinoid-related central nervous system side effects. We may also evaluate additional indications aligned with the compound’s pharmacological profile.
SKNY-1
For SKNY-1, our strategy is to advance a novel oral therapeutic targeting obesity and nicotine addiction through a multi-pathway mechanism involving CB1, CB2, and MAO-B modulation.
SKNY-1 is currently in preclinical development, and we are preparing for IND-enabling studies, including additional pharmacology, safety, and toxicology assessments. We plan to conduct further studies in relevant animal models to support its therapeutic potential in metabolic and addiction-related indications.
Our objective is to position SKNY-1 as a differentiated oral therapy with potential dual-indication utility, and we intend to evaluate strategic development and partnering opportunities as the program advances.
Strategic Focus
Across our pipeline, we intend to:
| ● | Advance programs through key value-inflection points, including clinical proof-of-concept | |
| ● | Prioritize indications with significant unmet medical need and limited treatment options | |
| ● | Maintain capital-efficient development pathways | |
| ● | Explore strategic collaborations, licensing opportunities, or other transactions to support development and commercialization |
Our goal is to build a portfolio of differentiated therapeutic candidates with the potential to address large and underserved markets while maximizing long-term shareholder value.
Preclinical Research and Pharmacology
Ketamir-2
Ketamir-2 has been evaluated in a series of in vitro and in vivo preclinical studies designed to characterize its pharmacological activity, receptor selectivity, and therapeutic potential.
Preclinical studies indicate that Ketamir-2 is a low-affinity NMDA receptor antagonist that selectively binds to the phencyclidine (PCP) site, with reduced off-target receptor interactions compared to ketamine. In animal models of neuropathic pain, including established rodent models, Ketamir-2 demonstrated improvements in pain thresholds relative to baseline. Behavioral assessments also indicated activity in models commonly used to evaluate anxiety- and depression-related endpoints.
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Pharmacokinetic and metabolism studies suggest that Ketamir-2 is orally bioavailable, crosses the blood-brain barrier, and is metabolized primarily through N-demethylation pathways. Preclinical findings may not be predictive of clinical outcomes.
MIRA-55
MIRA-55 has been evaluated in preclinical studies assessing receptor pharmacology, behavioral effects, and activity in pain and inflammation models.
In vitro receptor-binding and functional assays indicate that MIRA-55 exhibits preferential activity at CB2 receptors relative to CB1 receptors. In comparative studies, MIRA-55 demonstrated greater potency at CB2 receptors than certain reference cannabinoids in GPCR-based assays.
In animal models, MIRA-55 demonstrated activity in behavioral assays, including the Elevated Plus Maze, suggesting anxiolytic-like effects without evidence of sedation or motor impairment. In addition, MIRA-55 showed activity in thermal and inflammatory pain models, including increased latency in hot plate testing and reduction of inflammatory responses in established models.
Additional studies have evaluated cognitive and behavioral endpoints to assess potential central nervous system effects. Across multiple assays, MIRA-55 did not demonstrate cannabinoid-like adverse behavioral effects observed with certain CB1-active compounds. Preclinical findings may not be predictive of clinical outcomes.
SKNY-1
SKNY-1 has been evaluated in preclinical metabolic and behavioral models relevant to obesity and addiction.
In zebrafish models of obesity and craving behavior, oral administration of SKNY-1 was associated with reductions in food consumption, body weight, and nicotine-seeking behavior compared to controls. Weight reduction observed in these studies was not associated with evidence of muscle loss.
Mechanistically, SKNY-1 is designed to modulate multiple pathways involved in appetite and reward, including CB1, CB2, and MAO-B. Preclinical data suggest that SKNY-1 may influence energy balance, metabolic activity, and craving-related behaviors.
These findings support continued preclinical development of SKNY-1. Preclinical findings may not be predictive of clinical outcomes.
The Company’s product candidates are being developed to address significant unmet needs across large and growing therapeutic markets, including neuropathic pain, inflammatory pain, obesity, and nicotine dependence. These markets are characterized by limitations in existing therapies, including safety, tolerability, and long-term efficacy. The Company believes its differentiated pipeline is positioned to address these gaps.
The Company operates in highly competitive therapeutic areas, with numerous pharmaceutical and biotechnology companies developing treatments targeting neuropathic pain, inflammatory pain, obesity, and nicotine dependence. Many of these competitors have substantially greater financial, technical, and commercial resources.
Regulation
The FDA and comparable regulatory authorities in state and local jurisdictions impose substantial and burdensome requirements upon companies involved in the clinical development, manufacture, marketing, and distribution of drugs. These agencies and other federal, state, and local entities regulate, among other things, the research and development, testing, manufacture, quality control, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion, distribution, post-approval monitoring and reporting, sampling and export and import of our drug candidates.
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U.S. Government Regulation
In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and its implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval, may subject an applicant to a variety of administrative or judicial sanctions, such as the FDA’s refusal to approve pending New Drug Applications (or NDAs), withdrawal of an approval, imposition of a clinical hold, issuance of warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.
The process required by the FDA before a drug may be marketed in the United States generally involves the following:
| ● | completion of pre-clinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice (“GLP”) regulations; |
| ● | submission to the FDA of an IND application, which must become effective before human clinical trials may begin; |
| ● | approval by an independent Institutional Review Board (“IRB”), at each clinical site before each trial may be initiated; |
| ● | performance of adequate and well-controlled human clinical trials in accordance with good clinical practices (“GCP”) requirements to establish the safety and efficacy of the proposed drug product for each indication; |
| ● | demonstration that the API and finished product are manufactured under well controlled (eventually cGMP) conditions and meet all applicable standards of identity, strength, quality, and purity; |
| ● | submission to the FDA of an NDA; |
| ● | satisfactory completion of an FDA advisory committee review, if applicable; |
| ● | satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with cGMP requirements and to assure that the facilities, methods, and controls are adequate to preserve the drug’s identity, strength, quality, and purity; |
| ● | FDA review and approval of the NDA, including consideration of the views of any FDA advisory committee, prior to commercial marketing or sale of the drug in the United States; and |
| ● | compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy (“REMS”) or to conduct a post-approval study. |
Pre-clinical studies
Before testing any drug or biological product candidate in humans, the product candidate must undergo rigorous pre-clinical testing. The pre-clinical developmental stage generally involves laboratory evaluations of drug chemistry, formulation, and stability, as well as studies to evaluate toxicity in animals, to assess the potential for adverse events (“AEs”) and, in some cases, to establish a rationale for therapeutic use. The conduct of pre-clinical studies is subject to federal regulations and requirements, including GLP regulations for safety/toxicology studies. An IND sponsor must submit the results of the pre-clinical studies, together with manufacturing information, analytical data, any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND.
An IND is a request for authorization from the FDA to ship an investigation product and then administer it to humans and must be allowed to proceed by the FDA before human clinical trials may begin. Some long-term pre-clinical testing, such as animal tests of reproductive AEs and carcinogenicity, may continue after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions before that time related to one or more proposed clinical trials and places the trial on clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. As a result, submission of an IND may not result in the FDA allowing clinical trials to commence.
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Clinical trials
The clinical stage of development involves the administration of the investigational product to healthy volunteers or patients under the supervision of qualified investigators, generally physicians not employed by, or under control of, the trial sponsor, in accordance with GCPs, which include the requirement that all research patients provide their informed consent for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria and the parameters to be used to monitor subject safety and assess efficacy. Each protocol, and any subsequent amendments to the protocol, must be submitted to the FDA as part of the IND. Furthermore, each clinical trial must be reviewed and approved by an IRB for each institution at which the clinical trial will be conducted to ensure that the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the informed consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed. There also are requirements governing the reporting of ongoing clinical trials and completed clinical trial results to public registries. Information about most clinical trials must be submitted within specific timeframes for publication on the www.clinicaltrials.gov website. Information related to the product, patient population, phase of investigation, study sites and investigators and other aspects of the clinical trial is made public as part of the registration of the clinical trial. Sponsors are also obligated to disclose the results of their clinical trials after completion. Disclosure of the results of these trials can be delayed in some cases for up to two years after the date of completion of the trial. Competitors may use this publicly available information to gain knowledge regarding the progress of development programs.
Human clinical trials are typically conducted in three sequential phases, which may overlap or be combined:
| ● | Phase I clinical trials generally involve a small number of healthy volunteers or disease-affected patients who are initially exposed to a single dose and then multiple doses of the product candidate. The primary purpose of these clinical trials is to assess the metabolism, pharmacologic action, side effect tolerability and safety of the drug. |
| ● | Phase II clinical trials involve studies in disease-affected patients to determine the dose required to produce the desired benefits. At the same time, safety and further pharmacokinetic and pharmacodynamic information is collected, possible adverse effects and safety risks are identified, and a preliminary evaluation of efficacy is conducted. |
| ● | Phase III clinical trials generally involve a larger number of patients at multiple sites and are designed to provide the data necessary to demonstrate the effectiveness of the product for its intended use, its safety in use and to establish the overall benefit/risk relationship of the product and provide an adequate basis for product approval. These trials may include comparisons with placebo and/or other comparator treatments. The duration of treatment is often extended to mimic the actual use of a product during marketing. |
Post-approval trials, sometimes referred to as Phase IV clinical trials, may be conducted after initial marketing approval. These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow up. In certain instances, the FDA may mandate the performance of Phase IV clinical trials as a condition of approval of an NDA or a Biologics License Application (“BLA”).
Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if significant adverse events (“SAEs”) occur. The FDA or the sponsor may suspend or terminate a clinical trial at any time, or the FDA may impose other sanctions on various grounds, including a finding that the research patients are being exposed to an unacceptable health risk. Similarly, an IRB can refuse, suspend, or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients.
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Concurrently with clinical trials, companies usually complete additional pre-clinical studies and must also develop additional information about the physical characteristics of the drug or biological product as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the sponsor must develop methods for testing the identity, strength, quality, potency, and purity of the final biological product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the biological product candidate does not undergo unacceptable deterioration over its shelf life.
Marketing Approval
Assuming successful completion of the required clinical testing, the results of the pre-clinical studies and clinical trials, together with detailed information relating to the product’s chemistry, manufacture, controls, and proposed labeling, among other things, are submitted to the FDA as part of an NDA requesting approval to market the product for one or more indications. In most cases, the submission of an NDA is subject to a substantial application user fee.
The review process typically takes twelve months from the date the NDA is submitted to the FDA. The FDA conducts a preliminary review of all NDAs within the first 60 days after submission to determine whether they are sufficiently complete to permit substantive review before accepting them for “filing.” The FDA may request additional information rather than accept an NDA for filing. In this event, the application must be resubmitted with the additional information and may be subject to an additional application user fee. The resubmitted application is also subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review. The FDA reviews an NDA to determine, among other things, whether the drug is safe and effective and whether the facility in which it is manufactured, processed, packaged, or held meets standards designed to assure the product’s continued safety, quality and purity. Under the current guidelines in effect in the Prescription Drug User Fee Act (PDUFA), the FDA has a goal to review and act on the submission within ten months from the completion of the preliminary review of a standard NDA for a new molecular entity.
The FDA also may require submission of a REMS plan to ensure that the benefits of the drug outweigh its risks. The REMS plan could include medication guides, physician communication plans, assessment plans, and/or elements to assure safe use, such as restricted distribution methods, patient registries, or other risk minimization tools.
The FDA may refer an application for a novel drug to an advisory committee. An advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.
Before approving an NDA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA, the FDA may inspect one or more clinical trial sites to assure compliance with GCP requirements.
After evaluating the NDA and all related information, including the advisory committee recommendation, if any, and inspection reports regarding the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a complete response letter. A complete response letter generally contains a statement of specific conditions that must be met in order to secure final approval of the NDA and may require additional clinical trials or pre-clinical studies in order for FDA to reconsider the application. Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. If and when those conditions have been met to the FDA’s satisfaction, the FDA will typically issue an approval letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.
Post-approval requirements
Drugs manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion and reporting of adverse experiences with the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims are subject to prior FDA review and approval. There also are continuing annual user fee requirements for any marketed products and the establishments at which such products are manufactured, as well as new application fees for supplemental applications with clinical data.
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Intellectual Property
KETAMIR-2
We license the U.S., Canadian, and Mexican patent rights for the use of KETAMIR-2 in human applications from MIRALOGX. MIRALOGX filed international application no. PCT/US2024/018594 under the Patent Cooperation Treaty (PCT) on March 6, 2024, titled, ANTIDEPRESSANT COMPOUNDS, PHARMACEUTICAL COMPOSITIONS, AND METHODS OF TREATING DEPRESSION AND OTHER DISORDERS, and in due course intends to enter the national phase in the United States, Canada and Mexico, among other countries. These applications, if granted and subject to payment of patent maintenance fees, would offer protection extending through at least March 6, 2044. The patent rights for KETAMIR-2 outside of the United States, Canada, and Mexico are not included in our current patent rights.
Our license from MIRALOGX is set forth in the Exclusive License Agreement, dated November 15, 2023, pursuant to which the licensed field of use includes therapeutic treatments and other medical or health uses in humans, and related preclinical studies and activities conducted in furtherance of obtaining regulatory approval for and commercialization of human therapeutic treatments and uses (the “MIRALOGX License Agreement”). “Licensed Product” is defined as a drug product containing as an active agent 2-(2-chlorophenyl)-2-(methylamino)cyclopentan-1-one or a pharmaceutically acceptable salt or ester thereof. We also have the right to grant corresponding sublicenses under the licensed patent rights. The MIRALOGX License Agreement provides for the payment to MIRALOGX of an 8% royalty (payable quarterly) on our net sales of Licensed Products by us or our sublicensees and on non-royalty bearing milestone revenue, with the royalty obligation ceasing upon the later of the expiration of the last-to-expire licensed patent. The agreement also provides for an up-front Cost Reimbursement of $100,000 payable to MIRALOGX to cover the already-incurred costs associated with the patent rights. The Cost Reimbursement is the only payment made to date under the agreement. MIRALOGX may terminate the agreement upon insolvency, an uncured breach including the failure to make any payment owed under the agreement or the failure to use commercially reasonable efforts to develop the licensed product, or upon a default of the November 15, 2023 Promissory Note and Loan Agreement. The MIRALOGX License Agreement provides that MIRALOGX will have sole control over the filing, prosecution, maintenance, and management of the licensed patent rights, provided that we will be responsible for the cost of prosecuting and maintaining the licensed patents. The agreement grants to us the primary right, but not the obligation, to enforce the licensed patent rights.
Besides relying on patents, we also rely on trade secrets, proprietary know-how and continuing innovation to develop and maintain our competitive position, especially when we do not believe that patent protection is appropriate or can be obtained. We seek protection of these trade secrets, proprietary know-how and any continuing innovation, in part, through confidentiality and proprietary information agreements. However, these agreements may not provide meaningful protection for, or adequate remedies to protect, our technology in the event of unauthorized use or disclosure of information. Furthermore, our trade secrets may otherwise become known to, or be independently developed by, our competitors. We intend to seek appropriate patent protection for technology in our research and development programs, where applicable, and their uses by filing patent applications in the United States and other selected countries. We intend for these patent applications to cover, where possible, claims for compositions of matter, medical uses, processes for preparation and formulations.
MIRA-55
We have a pending provisional patent application directed to MIRA-55, a structure that was synthesized and isolated during the research and development of MIRA1a titled “Synthetic Cannabinoid Analogs, Pharmaceutical Compositions and Methods of Treating Anxiety and Other Disorders”. The Company intends to pursue domestic and foreign filings based on the provisional application to seek global patent protection for MIRA-55.
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MIRA1a
The U.S. Patent 10,787,675 B2, titled “Purified Synthetic Marijuana and Methods of Treatment by Administering Same,” which covers the MIRA1a compound per se as a racemic mixture, an isolated R-enantiomer, or an isolated S-enantiomer, as well as pharmaceutical formulations of the compound, was assigned to our Company by SRQ Patent Holdings II, LLC (“SRQ”) in December 2021. This patent also covers MIRA1a in methods of treating Alzheimer’s disease, anxiety, depression, and addictions. Subject to payment of patent maintenance fees, the ‘675 patent offers protection extending through at least February 11, 2039. According to the assignment and royalty agreement, we owe 8% in royalty revenue on net sales price and royalty revenue and 8% of milestone payment revenue to SRQ.
The royalties shall continue, in each country on a product-by-product and country-by-country basis until the later of i) the date of expiration of the last to expire patent included within the Innovation, or ii) the date of expiration of the last strategic partnership/licensing agreement including the Innovation.
We currently have no plans to develop the MIRA1a compound for approval and commercialization in or outside of the United States. See “Risk Factors- Risks Related to Our Intellectual Property- We own the rights associated with our patents in the United States, but we do not own the rights to patents covering MIRA1a in foreign jurisdictions.”
SKNY-1
We hold a license in the U.S. and its territories, Mexico and Canada from MIRALOGX for the use of SKNY-1 in human applications. SKNY has filed international application no. PCT/US25/17127 under the Patent Cooperation Treaty (PCT) on February 25, 2025, titled “SYNTHETIC CANNABINOID ANALOGS, PHARMACEUTICAL COMPOSITIONS, AND METHODS OF TREATING ANXIETY AND OTHER DISORDERS,” and hold patent no. 63/653,326 on 5/30/24, titled “SYNTHETIC CANNABINOID ANALOGS, PHARMACEUTICAL COMPOSITIONS, AND METHODS OF TREATING BACTERIAL INFECTIONS AND VIRAL INFECTIONS,” and in due course intends to enter the national phase in the United States, among other countries. These applications, if granted and subject to payment of patent maintenance fees, would offer protection extending through at least February 25, 2045, and May 30, 2044, respectively. The patent rights for SKNY-1 outside of the United States are not included in the SKNY-1 licensing agreement.
Properties
Our current business address is 1200 Brickell Avenue, Suite 1950 #1183, Miami, Florida 33131, which is a virtual office.
Employees
As of March 28, 2026, we had two part time employees and various consultants providing support. None of our employees are represented by a labor union or are covered by a collective bargaining agreement. We consider our relationship with our employees to be satisfactory.
Legal Proceedings
From time to time, we may be named in claims arising in the ordinary course of business. Currently, no legal proceedings, government actions, administrative actions, investigations, or claims are pending against us or involve us that, in the opinion of our management, could reasonably be expected to have a material adverse effect on our business and financial condition.
We anticipate that we will expend significant financial and managerial resources in the defense of our intellectual property rights in the future if we believe that our rights have been violated. We also anticipate that we will expend significant financial and managerial resources to defend against claims that our products and services infringe upon the intellectual property rights of third parties.
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Corporation Information
Our corporate headquarters is located at 1200 Brickell Avenue, Suite 1950 #1183, Miami, Florida 33131. Our telephone number is 786-432-9792.
Our principal website address is www.mirapharmaceuticals.com. The information contained on, or that can be accessed through, our website is deemed not to be incorporated in this Report or to be part of this Report. You should not consider information contained on our website to be part of this Report.
ITEM 1A. Risk Factors
RISK FACTORS
Investing in shares of our common stock is very speculative and involves a high degree of risk. You should carefully consider the risks and uncertainties described below, the section of this Report entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes included elsewhere in this Report before investing in shares of our common stock. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that affect us. If any of the following risks occur, our business, operating results and prospects could be materially harmed. In that event, the price of our common stock could decline, and you could lose part or all of your investment.
Summary Risk Factors
Our business is subject to numerous risks and uncertainties that you should consider before investing in our company. You should carefully consider all of the risks described more fully in the section titled “Risk Factors” in this Annual Report on page 19, before deciding to invest in our common stock. If any of these risks actually occurs, our business, financial condition and results of operations would likely be materially adversely affected.
Important factors that could cause actual results or events to differ materially, but are not limited to, the following:
Risks Related to Our Operations and Financial Condition
We are an early development-stage company with no revenues.
The report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2025 contains an explanatory paragraph relating to our ability to continue as a going concern.
Because we have a limited operating history, you may not be able to accurately evaluate our operations.
We have significant and increasing liquidity needs and will require additional funding.
We have yet to generate revenues or achieve a profit and may not generate revenue or achieve a profit for many years, if at all.
Conflicts of interest may arise between us and MIRALOGX.
Certain of our executive officers will not be employed by us on a full-time basis.
Risks Relating to Our Business and Our Industry
We are dependent on our current and future product candidates, some of which may not receive regulatory approval or be successfully commercialized.
Results of pre-clinical studies and earlier clinical trials are not necessarily predictive indicators of future results.
Our product candidates, if approved, may be unable to achieve the expected market acceptance and, consequently, limit our ability to generate revenue from new products
.
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If product liability lawsuits are successfully brought against us, we will incur substantial liabilities and may be required to limit the commercialization of Ketamir-2 and MIRA-55 and our product candidates.
Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
Legislative or regulatory reform of the health care system in the U.S. may affect our ability to profitably sell our products, if approved.
Unfavorable global economic and geopolitical conditions could adversely affect our business, financial condition, stock price, and results of operations.
Risks Related to Development and Regulatory Approval of Our Product Candidates
Clinical trials for our product candidates are expensive, time-consuming, uncertain, and susceptible to change, delay or termination. The results of clinical trials are open to differing interpretations.
Clinical trials of synthetic cannabinoid drug candidates and ketamine analogs are novel with very limited or non-existing history; we face a significant risk that the trials will not result in commercially viable drugs and treatments.
The regulatory approval processes with the FDA are lengthy and inherently unpredictable.
There is a high rate of failure for drug candidates proceeding through clinical trials.
Risks Related to Our Reliance Upon Third Parties
Our existing collaboration arrangements and any that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our product candidates.
We depend on a limited number of suppliers for materials and components required to manufacture our product candidates.
We rely on, and expect to continue to rely on, third parties to conduct clinical trials for our product candidates.
Risks Related to Our Intellectual Property
We may not be able to adequately protect our product candidates or our proprietary technology in the marketplace.
We have no patent protection for MIRA-55, which could adversely impact MIRA-55’s potential competitive position.
Risks Related to SKNY and SKNY-1
SKNY has yet to generate revenues or achieve a profit and may not generate revenue or achieve a profit for many years, if at all.
SKNY does not own rights to SKNY-1
Conflicts of interest may arise between SKNY and MIRALOGX.
Risks Relating to the Ownership of our Common Stock
Because of the speculative nature of investment risk, you may lose your entire investment.
Certain of our founding stockholders, plus our existing officers and directors, control a substantial interest in us and thus may influence certain actions requiring stockholder vote.
Sales of a significant number of shares of our common stock in the public markets, or the perception that such sales could occur, could depress the market price of our common stock.
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If we fail to maintain compliance with Nasdaq Listing Rules, our shares may be delisted from Nasdaq, which would result in a limited trading market for our shares and make obtaining future debt or equity financing more difficult for the us.
Risks Related to Our Operations and Financial Condition
We are an early development-stage company with no revenues. As such, our losses from operations and negative cash flows as of December 31, 2025 raise substantial doubt about our ability to continue as a going concern absent obtaining adequate new debt or equity financings.
As a very early development-stage enterprise that is focused on the development of a pre-clinical pharmaceutical product, we have generated no revenue and have an accumulated deficit of $39.6 million through December 31, 2025, and $29.1 million through December 31, 2024. We have concluded that substantial doubt exists about our ability to continue as a going concern for the 12 months following the issuance of the financial statements included in this Annual Report on Form 10-K. As of the issuance date of these financial statements, we believe that we have sufficient resources available to support our development activities and business operations and timely satisfy our obligations as they come due into the third quarter of 2025. We do not have sufficient cash and cash equivalents as of the date of filing this Annual Report on Form 10-K to support our operations for at least the 12 months following the issuance of the financial statements.
To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, we plan to secure additional capital, potentially through a combination of public or private equity offerings and strategic transactions, including potential alliances and drug product collaborations, however, none of these alternatives are committed at this time. There can be no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all, identify and enter into any strategic transactions that will provide the capital that we will require or achieve the other strategies to alleviate the conditions that raise substantial doubt about our ability to continue as a going concern. If none of these alternatives are available, or if available, are not available on satisfactory terms, we will not have sufficient cash resources and liquidity to fund our business operations for at least the 12 months following the date the financial statements are issued. The failure to obtain sufficient capital on acceptable terms when needed may require us to delay, limit, or eliminate the development of business opportunities and our ability to achieve our business objectives and our competitiveness, and our business, financial condition, and results of operations will be materially adversely affected. In addition, the perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns about our ability to meet our contractual obligations.
Additionally, we filed a shelf registration statement with the SEC to facilitate the issuance of our common stock and entered into an At The Market Offering Agreement with Rodman & Renshaw LLC, under which we may offer and sell shares of our Common Stock. The maximum amount eligible to be sold under the ATM Agreement is $75 million. However, although we have received net proceeds of $6.7 million for the year ended December 31, 2025 and $3.6 million for the year ended December 31, 2024 from the ATM, there are no assurances that we will be successful in raising any additional capital from the ATM.
The report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2025 contains an explanatory paragraph relating to our ability to continue as a going concern.
The auditor’s opinion on our audited financial statements for the year ended December 31, 2025 includes an explanatory paragraph stating that we have no revenue and incurred recurring losses from operations and cash used in operations that raise substantial doubt about our ability to continue as a going concern. While we believe that we will be able to obtain the capital we need to continue our operations, there can be no assurances that we will be successful in these efforts or will be able to resolve our liquidity issues or eliminate our operating losses. If we are unable to obtain sufficient funding, we would need to significantly reduce our operating plans and curtail some or all of our development efforts. Accordingly, our business, prospects, financial condition, and results of operations will be materially and adversely affected, and we may be unable to continue as a going concern. If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding on commercially reasonable terms or at all.
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Because we have a limited operating history, you may not be able to accurately evaluate our operations.
We have had limited operations to date. Therefore, we have a limited operating history upon which to evaluate the merits of investing in our company. Potential investors should be aware of the difficulties normally encountered by new companies and the high rate of failure of such enterprises. The likelihood of success must be considered in light of the problems, expenses, difficulties, complications, and delays encountered in connection with the operations that we plan to undertake. These potential problems include, but are not limited to, unanticipated problems relating to the ability to generate sufficient cash flow to operate our business, and additional costs and expenses that may exceed current estimates. We expect to continue to incur significant losses into the foreseeable future. We recognize that if the effectiveness of our business plan is not forthcoming, we will not be able to continue business operations. There is no history upon which to base any assumption as to the likelihood that we will prove successful, and it is doubtful that we will generate any operating revenues or ever achieve profitable operations. If we are unsuccessful in addressing these risks, our business will most likely fail.
We have significant and increasing liquidity needs and will require additional funding.
Our operations have consumed substantial amounts of cash since inception. For the year ended December 31, 2025, we reported a net operating cash outflow of $4.6 million and a net cash inflow from financing activities of $8.2 million. For the year ended December 31, 2024, we reported a net operating cash outflow of $5.6 million and a net cash inflow from financing activities of $3.8 million.
Research and development, and general and administrative expenses, and cash used for operations will continue to be significant and may increase substantially in the future in connection with new research and development initiatives and continued product commercialization efforts. We may need to raise additional capital to fund our operations, continue to conduct clinical trials to support potential regulatory approval of marketing applications and to fund commercialization of our products.
The amount and timing of our future funding requirements will depend on many factors, including, but not limited to:
| ● | the timing of FDA approval, if any; |
| ● | the DEA continuing to classify Ketamir-2 as a substance not subject to CSA; |
| ● | the DEA continuing to classify MIRA-55 as a substance not subject to CSA; |
| ● | the timing and amount of revenue from sales of our products, or revenue from grants or other sources; |
| ● | the rate of progress and cost of our clinical trials and other product development programs; |
| ● | costs of establishing or outsourcing sales, marketing, and distribution capabilities; |
| ● | costs and timing of completion of expanded in-house manufacturing facilities as well as any outsourced commercial manufacturing supply arrangements for our product candidates; |
| ● | costs of filing, prosecuting, defending, and enforcing any patent claims and other intellectual property rights associated with our product candidates; |
| ● | costs of operating as a U.S. public company; |
| ● | the effect of competing technological and market developments; |
| ● | personnel, facilities, and equipment requirements; and |
| ● | the terms and timing of any additional collaborative, licensing, co-promotion, or other arrangements that we may establish. |
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While we expect to fund our future capital requirements from a number of sources including existing cash balances, future cash flows from operations and the proceeds from further public offerings, we cannot assure you that any of these funding sources will be available to us on favorable terms, or at all. Further, even if we can raise funds from all of the above sources, the amounts raised may not be sufficient to meet our future capital requirements.
Operating results may vary significantly in future periods.
Our operating and financial results are likely to fluctuate significantly in the future. Our operating and financial results are unpredictable and may fluctuate, for among other reasons, due to:
| ● | our achievement of product development objectives and milestones; |
| ● | clinical trial enrollment and expenses; |
| ● | research and development expenses; and |
| ● | the timing and nature of contract manufacturing and contract research payments. |
In addition, a high portion of our costs are determined on an annual basis, due in part to our significant research and development costs. Thus, increases in our costs could disproportionately affect financial results in a quarter. Other factors, including non-cash expenses associated with financing activity, could also lead to fluctuations in our results of operations. Because of these factors, our operating and financial results in one or more future quarters may fail to meet the expectations of securities analysts or investors, which could cause our share price to decline.
We have yet to generate revenues or achieve a profit and may not generate revenue or achieve a profit for many years, if at all.
We have not yet produced any revenues or profit and may not for many years, if at all. Our ability to generate revenue is dependent on the receipt of regulatory approval of our product candidates, which will take years to achieve and may not be obtained. We therefore cannot assure you we will be able to ever generate sufficient revenue to pay for our expenses or achieve profitability. Our ability to continue as a going concern in the future is dependent upon raising capital from financing transactions and keeping operating expenses below our revenue levels in order to achieve positive cash flows, none of which can be assured.
Conflicts of interest may arise between us and MIRALOGX.
MIRALOGX licenses us the patent pending rights to KETAMIR-2. MIRALOGX is a separate intellectual property development company owned by the Bay Shore Trust. The Bay Shore Trust is also our largest stockholder. The interests of MIRALOGX are 100% owned by the Bay Shore Trust. Our relationship with MIRALOGX and the Bay Shore Trust may create, or may create the appearance of, conflicts of interest when we are faced with decisions that could have different implications for MIRALOGX than the decisions have for us. Furthermore, in light of the license agreement that we have with MIRALOGX, if a dispute were to arise between MIRALOGX and us relating to our past or future relationship with MIRALOGX or with respect to intellectual property matters, these potential conflicts of interest may make it more difficult for us to favorably resolve such disputes. Mr. Aminov, the Chief Executive Officer of the Company, is also the son-in-law of Jonnie Williams, the owner of MIRALOGX.
Certain of our executive officers will not be employed by us on a full-time basis.
Erez Aminov, our Chief Executive Officer and Chairman of our board of directors, is not employed by our company on a full-time basis. As intended to be provided in his employment agreement with our company, he works on a part-time and as-needed basis. Because he does not work full time for our company, instances may occur where he may not be immediately available to provide solutions to problems or address concerns that arise in the course of us conducting our business and thus adversely affect our business. In addition, he can become subject to conflicts of interest because he devotes part of his working time to other business endeavors and may have responsibilities to other entities. Although Mr. Aminov is aware of his duties and accountability to our company and to applicable laws and policies relating to corporate opportunity and conflicts of interest, such conflicts of interest may include deciding how much time to devote to our affairs, as well as what business opportunities should be presented to us.
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Alan Weichselbaum, our Chief Financial Officer, is not employed by our company on a full-time basis. Because he does not work full time for our company, instances may occur where he may not be immediately available to provide solutions to problems or address concerns that arise in the course of us conducting our business and thus adversely affect our business. In addition, he can become subject to conflicts of interest because he devotes part of his working time to other business endeavors and may have responsibilities to other entities. Although Mr. Weichselbaum is aware of his duties and accountability to our company and to applicable laws and policies relating to corporate opportunity and conflicts of interest, such conflicts of interest may include deciding how much time to devote to our affairs, as well as what business opportunities should be presented to us.
Risks Relating to Our Business and Our Industry
Our future viability will largely depend on the positive development of Ketamir-2 and MIRA-55, and any future product candidates, which development will require significant capital resources and years of clinical development effort.
We currently have no drug products on the market, and all of our drug development projects are in a pre-clinical stage of development or moving into clinical stages. Our business depends almost entirely on the successful pre-clinical and clinical development, FDA regulatory approval, and commercialization of our product candidates, principally Ketamir-2 and MIRA-55. Investors need to be aware that substantial additional investments including pre-clinical and clinical development and FDA regulatory submission and approval efforts will be required before we are permitted to undertake clinical studies and market and commercialize our product candidates, if ever. It may be several years before we can commence clinical trials, if ever. Any clinical trial will be subject to extensive and rigorous review and regulation by numerous government authorities in the United States and other jurisdictions where we intend, if approved, to market our product candidates. Before obtaining regulatory approvals for any of our product candidates, we must demonstrate through pre-clinical testing and clinical trials that the product candidate is safe and effective for its specific application. This process can take many years and may include post-marketing studies and surveillance, which would require the expenditure of substantial resources. Of the large number of drugs in development for approval in the United States (and the rest of the world), only a small percentage will successfully complete the FDA regulatory approval financing to fund our planned research, development, and clinical programs, we cannot assure you that any of our product candidates will be successfully developed or commercialized.
We may be unable to formulate or scale up any or all of our product candidates. There is no guarantee that any of the product candidates will be or are able to be manufactured or produced in a manner to meet the FDA’s criteria for product stability, content uniformity and all other criteria necessary for product approval in the United States and other markets. Any of our product candidates may fail to achieve their specified endpoints in clinical trials.
Furthermore, product candidates may not be approved even if they achieve their specified endpoints in clinical trials. The FDA may disagree with our trial design and our interpretation of data from clinical trials or may change the requirements for approval even after it has reviewed and commented on the design for our clinical trials. The FDA may also approve a drug for fewer or more limited indications than we request or may grant approval contingent on the performance of costly post-approval clinical trials (i.e., Phase IV trials). In addition, the FDA may not approve the labeling claims that we believe are necessary or desirable for the successful commercialization of our product candidates.
If we are unable to obtain regulatory approval for Ketamir-2, MIRA-55 and SKNY-1 within the timeline we anticipate, we will not be able to execute our business strategy effectively and our ability to substantially grow our revenues will be limited, which would have a material adverse impact on our long-term business, results of operations, financial condition, and prospects.
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We are dependent on our current and future product candidates, some of which may not receive regulatory approval or be successfully commercialized.
Our ability to progress our plan will depend on our ability to clinically develop, gain regulatory approval for and ultimately commercialize our product candidates. Our ability to successfully commercialize our product candidates will depend on, among other things, our ability to:
| ● | successfully complete pre-clinical and other nonclinical studies and clinical trials in a manner that allows us to progress our product candidates; |
| ● | receive IND acceptance and regulatory approvals from the FDA; |
| ● | produce, through a validated process, in manufacturing facilities inspected and approved by regulatory authorities, including the FDA, sufficiently large quantities of product candidates to permit successful commercialization; |
| ● | obtain reimbursement from payers such as government health care programs and insurance companies and achieve commercially attractive levels of pricing; |
| ● | secure acceptance of our product candidates from physicians, health care payers, patients, and the medical community; |
| ● | create positive publicity surrounding our product candidates; |
| ● | manage our spending as costs and expenses increase due to clinical trials and commercialization; and |
| ● | obtain and enforce sufficient intellectual property for our product candidates. |
Our failure or delay with respect to any of the factors above could have a material adverse effect on our business, results of operations and financial condition.
Impact of global tensions may increase uncertainty of our future operations.
The global tensions arising from the Palestine-Israel war and the war in Ukraine may result in disruptions in the broader global economic environment. The uncertain nature, magnitude, and duration of hostilities stemming from such conflicts, including the potential effects of sanctions and countersanctions, or retaliatory cyber-attacks on the world economy and markets, have contributed to increased market volatility and uncertainty, which could have an adverse impact on macroeconomic factors that affect our business and operations, such as pre-clinical study issues, manufacturer delays or shipping delays.
Moreover, the conflict between Palestine and Israel could impact future business decisions to locate potential clinical trials in Israel. It is not possible to predict the short and long-term implications of military conflicts or wars or geopolitical tensions which could include further sanctions, uncertainty about economic and political stability, increases in inflation rate and energy prices, cyber-attacks, supply chain challenges and adverse effects on currency exchange rates and financial markets.
Results of pre-clinical studies and earlier clinical trials are not necessarily predictive indicators of future results.
Any positive results from future pre-clinical testing of our product candidates and potential future clinical trials may not necessarily be predictive of the results from Phase I, Phase II or Phase III clinical trials. In addition, our interpretation of results derived from clinical data or our conclusions based on our pre-clinical data may prove inaccurate. Frequently, pharmaceutical and biotechnology companies have suffered significant setbacks in clinical trials after achieving positive results in pre-clinical testing and early phase clinical trials, and we cannot be certain that we will not face similar setbacks. These setbacks may be caused by the fact that pre-clinical and clinical data can be susceptible to varying interpretations and analyses. Furthermore, certain product candidates may perform satisfactorily in pre-clinical studies and clinical trials but nonetheless fail to obtain FDA approval or appropriate approvals by the appropriate regulatory authorities in other countries. If we fail to produce positive results in our clinical trials for our product candidates, the development timeline and regulatory approval and commercialization prospects for them and as a result our business and financial prospects would be materially adversely affected.
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We have limited marketing experience, and we do not anticipate at this time establishing a sales force or distribution and reimbursement capabilities, and we may not be able to successfully commercialize any of our product candidates if they are approved in the future.
If regulatory approval of our products is ever obtained, our ability to generate revenues ultimately depends on our ability to sell our approved products and secure adequate third-party reimbursement. We currently have limited experience in marketing and selling our products. We currently do not have any products approved for sale in the United States or in any other country.
The commercial success of our product candidates will not even be possible for the foreseeable future and will depend on a number of factors beyond our control, including the willingness of physicians to prescribe our products to patients, payers’ willingness and ability to pay for the drugs, the level of pricing achieved, patients’ response to our drugs and the ability of our marketing partners to generate sales. There can be no guarantee that we will be able to establish or maintain the personnel, systems, arrangements and capabilities necessary to successfully commercialize Ketamir-2 and MIRA-55 or any product candidate approved by the FDA in the future. If we fail to establish or maintain successful marketing, sales and reimbursement capabilities or fail to enter into successful marketing arrangements with third parties, our product revenues may suffer.
Our product candidates, if approved, may be unable to achieve the expected market acceptance and, consequently, limit our ability to generate revenue from new products.
Even when product development is successful and regulatory approval has been obtained, our ability to generate sufficient revenue depends on the acceptance of our products by physicians and patients. We cannot assure you that our product candidates will achieve the expected level of market acceptance and revenue if and when they obtain the requisite regulatory approvals. The market acceptance of any product depends on a number of factors, including the indication statement and warnings required by regulatory authorities in the product label. Market acceptance can also be influenced by continued demonstrations of efficacy and safety in commercial use, physicians’ willingness to prescribe the product, reimbursement from third-party payers such as government health care programs and private third-party payers, the price of the product, the nature of any post-approval risk, management activities mandated by regulatory authorities, competition, and marketing and distribution support. Further, an ineffective or inefficient distribution model at launch may lead to the inability to fulfill demand, and consequently a loss of revenue. Any factors preventing or limiting the market acceptance of our products could have a material adverse effect on our business, results of operations and financial condition.
If the price for any future approved products decreases or if government and other third-party payers do not provide coverage and adequate reimbursement levels, our revenue and prospects for profitability will suffer.
Patients who are prescribed medicine for the treatment of their conditions generally rely on third-party payers to reimburse all or part of the costs associated with their prescription drugs. Reimbursement systems in international markets vary significantly by country and by region, and reimbursement approvals generally must be obtained on a country-by-country basis. Coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payers is critical to new product acceptance. Coverage decisions may depend upon clinical and economic standards that disfavor new drug products when more established or lower-cost therapeutic alternatives are already available or subsequently become available. Even if we obtain coverage for products we may market, the resulting reimbursement payment rates may require co-payments that patients find unacceptably high. Patients may not use our products if coverage is not provided, or reimbursement is inadequate to cover a significant portion of their cost.
In addition, the market for our products will depend significantly on access to third-party payers’ drug formularies or lists of medications for which third-party payers provide coverage and reimbursement. The industry competition to be included in such formularies often leads to downward pricing pressures on pharmaceutical companies. Also, third-party payers may refuse to include a particular branded drug in their formularies or otherwise restrict patient access to a branded drug when a less costly generic equivalent or other alternative is available, even if not approved for the indications for which our products are approved.
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Third-party payers or governmental or commercial entities are developing increasingly sophisticated methods of controlling healthcare costs. The current environment is putting pressure on companies to price products below what they may feel is appropriate. Selling our products at less than an optimized price could impact our revenues and overall success as a company. It will be difficult to determine the optimized price for our products. In addition, in the U.S., no uniform policy of coverage and reimbursement for drug products exists among third-party payers. Therefore, coverage and reimbursement for our products may differ significantly from payer to payer. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products to each payer separately, with no assurance that coverage will be obtained. If we are unable to obtain coverage of, and adequate payment levels for, products we may market to third-party payers, physicians may limit how much or under what circumstances they will prescribe or administer them, and patients may decline to purchase them. This in turn could affect our ability to successfully commercialize products we may market, and thereby adversely impact our profitability, results of operations, financial condition, and future success.
In addition, where we have chosen to collaborate with a third party on product candidate development and commercialization, our partner may elect to reduce the price of our products in order to increase the likelihood of obtaining reimbursement approvals. In many countries, products cannot be commercially launched until reimbursement is approved and the negotiation process in some countries can exceed 12 months. In addition, pricing and reimbursement decisions in certain countries can be affected by decisions taken in other countries, which can lead to mandatory price reductions and/or additional reimbursement restrictions across a number of other countries, which may thereby adversely affect our sales and profitability. In the event that countries impose prices that are not sufficient to allow us or our partners to generate a profit, our partners may refuse to launch the product in such countries or withdraw the product from the market, which would adversely affect sales and profitability. Events, such as price decreases, government mandated rebates or unfavorable reimbursement decisions, could affect the pricing and reimbursement of Ketamir-2 and MIRA-55 and our other product candidates and could have a material adverse effect on our business, reputation, results of operations and financial condition.
We expect to face intense competition, often from companies with greater resources and experience than we have.
Demand for ketamine analogs like Ketamir-2 and synthetic cannabinoids such as MIRA-55 and will likely be dependent on a number of social, political, legislative, and economic factors that are beyond our control. While we believe that there will be a demand for such drugs, and that the demand will grow, there is no assurance that such demand will happen, that we will benefit from any demand or that our business, in fact, will ever generate revenues from our drug development programs or become profitable.
The emerging markets for product candidates like ours and related medical research and development is and will likely remain competitive. The development and commercialization of drugs and medicines is highly competitive. We compete with a variety of multinational pharmaceutical companies and specialized biotechnology companies, as well as products and processes being developed by universities and other research institutions. Many of our competitors have developed, are developing, or will develop drugs and processes which may be competitive with our drug candidates. Competitive therapeutic treatments include those that have already been approved by medicines regulators and accepted by the medical community and any new treatments that may enter the market. For some of our drug development programs / areas of therapeutic interest, other treatment options are currently available, under development, and may become commercially available in the future. If any of our product candidates are approved for the diseases and conditions we are currently pursuing, they may compete with a range of medicines or therapeutic treatments that are either in development, will be developed in the future or currently marketed.
Established companies may have a competitive advantage over us due to their size and experiences, financial resources, and institutional networks. Many of our competitors may have significantly greater financial, technical, and human resources than we do. Due to these factors, our competitors may have an advantage in marketing their approved drugs and may obtain regulatory approval of their drug candidates before we are able to, which may limit our ability to develop or commercialize our drug candidates. Our competitors may also develop drugs / medicines that are safer, more effective, more widely used and less expensive than ours. These advantages could materially impact our ability to develop and, if approved, commercialize our product candidates successfully. Furthermore, some of these competitors may make acquisitions or establish collaborative relationships among themselves or with third parties to increase their ability to rapidly gain market share.
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Our product candidates may compete with other synthetic cannabinoids, as well as with cannabinoid or cannabis-based drugs, in addition to competing with state-licensed medical and recreational marijuana, in markets where the recreational and/or medical use of marijuana is legal. There is continuing support in the U.S. for further state legalization of marijuana. In markets where recreational and/or medical marijuana is not legal, our product candidates, once approved by regulators, may compete with marijuana or marijuana-based products purchased in the illegal drug market. This may or may not affect the commercial price that we may be able to achieve for our synthetic regulatory-approved medicines, should they be approved by the FDA.
Moreover, as generic versions of drug products enter the market, the price for such medicines may be expected to decline rapidly and substantially. Even if we are the first to obtain FDA approval of one of our product candidates, the future potential approval of generics could adversely affect the price we are able to charge, and the profitability of our product(s) will likely decline.
Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in more resources being concentrated among a smaller number of our competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.
These companies may compete with us in recruiting and retaining qualified scientific, management and commercial personnel, utilizing contract manufacturing facilities or contract research organizations (CROs), or establishing clinical trial sites and subject registration for clinical trials, as well as in acquiring technologies complementary to our research projects.
Product shipment delays could have a material adverse effect on our business, results of operations and financial condition.
The shipment, import and export of Ketamir-2 and MIRA-55 and our other product candidates require import and export licenses. In the U.S., FDA, U.S. Customs and Border Protection and the DEA, and in other countries similar regulatory authorities, regulate the import and export of pharmaceutical products that contain controlled substances. Specifically, the import and export process require the issuance of import and export licenses by the relevant controlled substance authority in both the importing and exporting countries. We may not be granted, or if granted, maintain such licenses from the authorities in certain countries. Even if we obtain the relevant licenses, shipments of Ketamir-2 and MIRA-55 and our product candidates may be held up in transit, which could cause significant delays and may lead to product batches being stored outside required temperature ranges. Inappropriate storage may damage the product shipment resulting in a partial or total loss of revenue from one or more shipments of Ketamir-2 and MIRA-55 or our other product candidates. A partial or total loss of revenue from one or more shipments of Ketamir-2 and MIRA-55 or our other product candidates could have a material adverse effect on our business, results of operations and financial condition. Even though the DEA has confirmed in writing that it conducted a scientific review of the chemical structure of MIRA1a and Ketamir-2 in accordance with the definitions within the CSA and its implementing regulations and determined that MIRA1a and Ketamir-2 is not a controlled substance or listed chemical, there is no assurance that the DEA may not change its position. We have filed the necessary requirements with the DEA to review MIRA-55, however, there can be no assurance that the DEA will conclude that MIRA-55 is not a controlled substance or listed chemical.
The manufacture of our product candidates is complex and uncertain, and until we develop a validated manufacturing process, we may encounter difficulties in supplying our planned and future clinical trials. If we encounter such difficulties, or fail to meet quality standards, our ability to meet clinical timelines and expand our development strategy could be impacted.
The processes involved in manufacturing Ketamir-2, MIRA-55 and other product candidates are complex, expensive, highly regulated and subject to multiple risks and uncertainties. We have been faced with issues such as this in the initial synthesis of MIRA-55 (which we initially believed was based on our patented MIRA1a molecule).
In addition, as product candidates are developed through early-to-late-stage clinical trials and then to approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods, are modified along the way to optimize the scale, process and results. Any changes to the manufacturing processes carry the risk that they will not achieve these intended objectives, or that the product candidates may not meet the rigorous quality standards necessary for use in our pre-clinical or clinical trials.
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Also, if planned or future manufacturing of Ketamir-2, MIRA-55 or other product candidates fails to meet the quality standards for use in our pre-clinical or clinical trials, or the active drug substance does not meet our quality specifications, it could impact our timelines and limit our development strategy. For example, and as discussed above, in the first quarter of 2024, we concluded that during the manufacturing and scale-up process of MIRA1a, the intended MIRA1a compound was in fact synthesized as MIRA-55.
Moreover, our contract manufacturing organizations (“CMOs”) or contract development and manufacturing organization (“CDMOs”) may be unable to successfully increase the manufacturing scale for our product candidates in a timely or cost-effective manner and may experience delays due to limited manufacturing capacity. In addition, quality issues may arise during manufacturing activities. If our CMOs or CDMOs are unable to successfully manufacture our product candidates in sufficient quantity in a timely manner or produce active drug substances that do not meet our quality specifications, our planned pre-clinical or clinical trials may be delayed or modified.
We may fail to expand our manufacturing capability in time to meet market demand for our products and product candidates, and the FDA may refuse to accept our facilities or those of our contract manufacturers as being suitable for the production of our products and product candidates. Any problems in our manufacturing process could have a material adverse effect on our business, results of operations and financial condition.
Before we can begin commercial manufacture of any product candidates for sale in the U.S., we must obtain FDA regulatory approval for the product, which requires a successful FDA inspection of our manufacturing facilities and those of our contract manufacturers, processes, and quality systems in addition to other product-related approvals. Although we may successfully navigate this pre-approval inspection process as it relates in the U.S., pharmaceutical manufacturing facilities are continuously subject to post-approval inspection by the FDA and foreign regulatory authorities. Due to the complexity of the processes used to manufacture our product candidates, we may be unable to initially or continue to pass federal, state or international regulatory inspections in a cost-effective manner. If we are unable to comply with manufacturing regulations, we may be subject to fines, unanticipated compliance expenses, recall or seizure of any approved products, total or partial suspension of production and/or enforcement actions, including injunctions, and criminal or civil prosecution. These possible sanctions would adversely affect our business, results of operations and financial condition.
Business interruptions could delay us in the process of developing our product candidates and could disrupt our product sales.
Our research and development activities are conducted through outside contractors and manufacturers. Loss of our contracted manufacturing facilities, stored inventory or laboratory facilities through fire, theft or other causes, or loss of our raw material, could have an adverse effect on our ability to continue product development activities and to conduct our business. Failure to supply our partners with commercial product may lead to adverse consequences, including the right of partners to take over responsibility for product supply. We currently do not have insurance coverage to compensate us for such business interruptions. Our contract manufacturers and suppliers provide that in their separate operations; however, such coverage may prove insufficient to fully compensate us for the damage to our business resulting from any significant property or casualty loss to those facilities.
If product liability lawsuits are successfully brought against us, we will incur substantial liabilities and may be required to limit the commercialization of Ketamir-2 and MIRA-55 and our product candidates.
Although we have never had any product liability claims or lawsuits brought against us, we face potential product liability exposure related to the testing of our product candidates in human clinical trials. We may face exposure to claims by an even greater number of persons when we begin to market and distribute our products commercially in the U.S., Europe and elsewhere. Now, and in the future, an individual may bring a liability claim against us alleging that Ketamir-2, MIRA-55 or one of our other product candidates caused an injury. While we continue to take what we believe are appropriate precautions, we may be unable to avoid significant liability if any product liability lawsuit is brought against us. Large judgments have been awarded in class action or individual lawsuits based on drugs that had unanticipated side effects. If we cannot successfully defend ourselves against product liability claims, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:
| ● | decreased demand for Ketamir-2, MIRA-55 or our other product candidates if such product candidates are approved; |
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| ● | injury to our reputation; |
| ● | withdrawal of clinical trial participants; |
| ● | costs of related litigation; |
| ● | substantial monetary awards to patients and others; |
| ● | increased cost of liability insurance; |
| ● | loss of revenue; and |
| ● | the inability to successfully commercialize our products. |
Counterfeit versions of our products could harm our business.
Counterfeiting activities and the presence of counterfeit products in a number of markets and over the Internet continue to be a challenge for maintaining a safe drug supply for the pharmaceutical industry. Counterfeit products are frequently unsafe or ineffective and can be life-threatening. To distributors and users, counterfeit products may be visually indistinguishable from the authentic version. Reports of adverse reactions to counterfeit drugs along with increased levels of counterfeiting could be mistakenly attributed to the authentic product, affect patient confidence in the authentic product and harm the business of companies such as ours. If our products were to be the subject of counterfeits, we could incur reputational and financial harm.
We depend upon our key personnel and our ability to attract and retain employees.
Our future growth and success depend on our ability to recruit, retain, manage, and motivate our employees. The inability to hire or retain experienced management personnel could adversely affect our ability to execute our business plan and harm our operating results. Due to the specialized scientific and managerial nature of our business, we rely heavily on our ability to attract and retain qualified scientific, technical, and managerial personnel. The competition for qualified personnel in the pharmaceutical field is intense. Due to this intense competition, we may be unable to continue to attract and retain the qualified personnel necessary for the development of our business or to recruit suitable replacement personnel.
Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to comply with FDA or foreign regulations, provide accurate information to FDA or other regulatory authorities, comply with applicable manufacturing standards, comply with other foreign, federal, and state laws and regulations, report information or data accurately or disclose unauthorized activities to us. Employee misconduct could also involve the improper use of information, including information obtained during clinical trials, or illegal appropriation of drug products, which could result in government investigations and serious harm to our reputation. The precautions we take to detect and prevent these prohibited activities may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.
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We are subject to the U.S. Foreign Corrupt Practices Act and other anti-corruption laws, as well as export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures, and legal expenses, which could adversely affect our business, results of operations and financial condition.
Our operations are subject to anti-corruption laws, including the U.S. Foreign Corrupt Practices Act of 1977, as amended (the “FCPA”), and other anti-corruption laws that apply in countries where we do business. The FCPA and these other laws generally prohibit us and our employees and intermediaries from bribing, being bribed or making other prohibited payments to government officials or other persons to obtain or retain business or gain some other business advantage. We and our commercial partners operate in a number of jurisdictions that pose a high risk of potential FCPA violations, and we participate in collaborations and relationships with third parties whose actions could potentially subject us to liability under the FCPA or local anti-corruption laws. In addition, we cannot predict the nature, scope, or effect of future regulatory requirements to which our international operations might be subject or the manner in which existing laws might be administered or interpreted.
We are also subject to other laws and regulations governing our international operations, including regulations administered by the government of the U.S. and other countries in which we operate or plan to operate, including applicable export control regulations, economic sanctions on countries and persons, customs requirements, and currency exchange regulations, (collectively referred to as the “Trade Control laws”).
However, there is no assurance that we will be completely effective in ensuring our compliance with all applicable anti-corruption laws, including the FCPA or other legal requirements, including Trade Control laws. If we are not in compliance with the FCPA and other anti-corruption laws or Trade Control laws, we may be subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses, which could have an adverse impact on our business, financial condition, results of operations and liquidity, as well as our reputation. Likewise, any investigation of any potential violations of the FCPA, other anti-corruption laws or Trade Control laws by the U.S. or other authorities could also have an adverse impact on our reputation, our business, results of operations and financial condition.
Our proprietary information, or that of our suppliers and business partners, may be lost or we may suffer security breaches.
In the ordinary course of our business, we will collect and store sensitive data, including valuable and commercially sensitive intellectual property, clinical trial data, our proprietary business information and that of our suppliers and business partners, and personally identifiable information of our clinical trial subjects and employees, on our networks, and with our third-party cloud service providers. The secure processing, maintenance and transmission of this information is critical to our operations. Despite our security measures, our information technology and infrastructure, and that of our third parties, may be vulnerable to attacks by hackers or breached due to employee error, malfeasance, or other disruptions. Any breach could compromise our networks and the information stored there could be accessed, publicly disclosed, lost, or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, regulatory penalties, disrupt our operations, damage our reputation, and cause a loss of confidence in our products and our ability to conduct clinical trials, which could adversely affect our business and reputation and lead to delays in gaining regulatory approvals for Ketamir-2 and MIRA-55 or other product candidates.
Failure of our information technology systems, including cybersecurity attacks or other data security incidents, could significantly disrupt the operation of our business.
Our business is increasingly dependent on critical, complex, and interdependent information technology (“IT”) systems, including internet-based systems, some of which are managed or hosted by third parties, to support business processes as well as internal and external communications. The size and complexity of our IT systems make us potentially vulnerable to IT system breakdowns, malicious intrusion, and computer viruses, which may result in the impairment of our ability to operate our business effectively.
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We are continuously evaluating and, where appropriate, enhancing our IT systems to address our planned growth, including to support our planned manufacturing operations. There are inherent costs and risks associated with implementing the enhancements to our IT systems, including potential delays in access to, or errors in, critical business and financial information, substantial capital expenditures, additional administrative time and operating expenses, retention of sufficiently skilled personnel to implement and operate the enhanced systems, demands on management time, and costs of delays or difficulties in transitioning to the enhanced systems, any of which could harm our business and results of operations. In addition, the implementation of enhancements to our IT systems may not result in productivity improvements at a level that outweighs the costs of implementation, or at all. In addition, our systems and the systems of our third-party providers and collaborators are potentially vulnerable to data security breaches which may expose sensitive data to unauthorized persons or to the public. Such data security breaches could lead to the loss of confidential information, trade secrets or other intellectual property, could lead to the public exposure of personal information (including personally identifiable information or individually identifiable health information) of our employees, clinical trial patients, customers, business partners, and others, could lead to potential identity theft, or could lead to reputational harm. Data security breaches could also result in loss of clinical trial data or damage to the integrity of that data. In addition, the increased use of social media by our employees and contractors could result in inadvertent disclosure of sensitive data or personal information, including but not limited to, confidential information, trade secrets and other intellectual property.
Any such disruption or security breach, as well as any action by us or our employees or contractors that might be inconsistent with the rapidly evolving data privacy and security laws and regulations applicable within the United States and elsewhere where we conduct business, could result in enforcement actions by U.S. states, the U.S. federal government or foreign governments, liability or sanctions under data privacy laws, including healthcare laws such as HIPAA, that protect certain types of sensitive information, regulatory penalties, other legal proceedings such as but not limited to private litigation, the incurrence of significant remediation costs, disruptions to our development programs, business operations and collaborations, diversion of management efforts and damage to our reputation, which could harm our business and operations. Because of the rapidly moving nature of technology and the increasing sophistication of cybersecurity threats, our measures to prevent, respond to and minimize such risks may be unsuccessful.
Security breaches, loss of data and other disruptions could compromise sensitive information related to our business, prevent us from accessing critical information or expose us to liability, which could adversely affect our business and our reputation.
In the ordinary course of our business, we, our vendors, and our third-party cloud service providers may collect and store sensitive data, including legally protected patient health information, credit card information, personally identifiable information about our employees and patients, intellectual property, and proprietary business information. We manage and maintain our applications and data utilizing cloud-based and on-site systems. These applications and data encompass a wide variety of business-critical information including research and development information, commercial information and business and financial information.
The secure processing, storage, maintenance, and transmission of this critical information is vital to our operations and business strategy, and we devote significant resources to protecting such information. Although we take measures to protect sensitive information from unauthorized access or disclosure, our information technology and infrastructure may be vulnerable to attacks by hackers, or viruses, breaches, or interruptions due to employee error, malfeasance or other disruptions, or lapses in compliance with privacy and security mandates. Any such virus, breach or interruption could compromise our networks and the information stored there could be accessed by unauthorized parties, publicly disclosed, lost or stolen. We have measures in place that are designed to prevent, and if necessary to detect and respond to such security incidents, breaches of privacy, and security mandates. However, in the future, any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, such as HIPAA in the United States and the General Data Protection Regulation in the European Union, or GDPR, government enforcement actions and regulatory penalties. Unauthorized access, loss or dissemination could also disrupt our operations, including our ability to process samples, provide test results, share and monitor safety data, bill payers or patients, provide customer support services, conduct research and development activities, process and prepare company financial information, manage various general and administrative aspects of our business and may damage our reputation, any of which could adversely affect our business, financial condition and results of operations.
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Legislative or regulatory reform of the health care system in the U.S. may affect our ability to profitably sell our products, if approved.
Our ability to commercialize our future products successfully, alone or with collaborators, will depend in part on the extent to which coverage and reimbursement for the products will be available from government and health administration authorities, private health insurers and other third-party payers. The continuing efforts of the U.S. government, insurance companies, managed care organizations and other payers for health care services to contain or reduce health care costs may adversely affect our ability to set prices for our products which we believe are fair, and our ability to generate revenues and achieve and maintain profitability.
Specifically, in the U.S., there have been a number of legislative and regulatory proposals to change the health care system in ways that could affect our ability to sell our products profitably. For example, certain states in the U.S. are proposing legislation mandating publicly funded health program coverage of medical cannabis. In addition, the 2010 Affordable Care Act, or the ACA, substantially changed the way healthcare is financed by both governmental and private insurers. Both Congress and the U.S. President have already taken some actions that are intended to significantly limit the ACA, and we expect efforts to further modify or repeal the ACA to continue. The success and potential effects of these efforts to repeal or modify the ACA are not clear.
We expect additional federal and state legislative proposals for health care reform, which could limit the prices that can be charged for the products we develop and may limit our commercial opportunity.
The continuing efforts of government and other third-party payers to contain or reduce the costs of health care through various means may limit our commercial opportunity. It will be time-consuming and expensive for us to go through the process of seeking coverage and reimbursement from Medicare, Medicaid, and other governmental health programs and from private payers. Our products may not be considered cost-effective, and government and third-party private health insurance coverage and reimbursement may not be available to patients for any of our future products or sufficient to allow us to sell our products on a competitive and profitable basis. Our results of operations could be adversely affected by ACA, changes to the ACA, and by other health care reforms that may be enacted or adopted in the future. In addition, increasing emphasis on managed care in the U.S. will continue to put downward pressure on the pricing of pharmaceutical products. Cost-control initiatives could decrease the price that we or any potential collaborators could receive for any of our future products and could adversely affect our ability to generate revenue in the U.S. market and maintain profitability.
Unfavorable global economic and geopolitical conditions could adversely affect our business, financial condition, stock price, and results of operations.
Our business could be adversely affected by unstable economic and political conditions within the United States and foreign jurisdictions, including as a result of an economic downturn and geopolitical events, such as changes in U.S. federal policy that affect the geopolitical landscape. Changes to policy implemented by the U.S. Congress, the Trump administration or any new administration have impacted and may in the future impact, among other things, the U.S. and global economy, international trade relations, unemployment, immigration, healthcare, taxation, the U.S. regulatory environment, inflation and other areas. For example, during the prior Trump administration, increased tariffs were implemented on goods imported into the U.S., particularly from China, Canada, and Mexico. On February 1, 2025, the U.S. imposed a 25% tariff on imports from Canada and Mexico, which were subsequently suspended for a period of one month, and a 10% additional tariff on imports from China. Historically, tariffs have led to increased trade and political tensions, between not only the U.S. and China, but also between the U.S. and other countries in the international community. In response to tariffs, other countries have implemented retaliatory tariffs on U.S. goods. Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange and other economic activities between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global financial markets. Any changes in political, trade, regulatory, and economic conditions, including U.S. trade policies, could have a material adverse effect on our financial condition or results of operations. Until we know what policy changes are made, whether those policy changes are challenged and subsequently upheld by the court system and how those changes impact our business and the business of our competitors over the long term, we will not know if, overall, we will benefit from them or be negatively affected by them.
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The global credit and financial markets have also generally experienced extreme volatility and disruptions (including as a result of actual or perceived changes in interest rates, inflation and macroeconomic uncertainties), which has included severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, high inflation, uncertainty about economic stability, global supply chain disruptions, and increases in unemployment rates. The financial markets and the global economy may also be adversely affected by military conflict, including the ongoing conflicts between Russia and Ukraine, and Israel and Hamas, terrorism, or other geopolitical events. Sanctions imposed by the United States and other countries in response to such conflicts, including the one in Ukraine, may also continue to adversely impact the financial markets and the global economy, and any economic countermeasures by the affected countries or others could exacerbate market and economic instability. There can be no assurance that further deterioration in credit and financial markets and confidence in economic conditions will not occur. A severe or prolonged economic downturn could result in a variety of risks to our business.
In addition, current inflationary trends in the global economy may impact salaries and wages, costs of goods and transportation expenses, among other things, and recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures may create market and economic instability. We cannot anticipate all of the ways in which the foregoing, and the current economic climate and financial market conditions generally, could adversely impact our business.
We may acquire other companies which could divert our management’s attention, result in additional dilution to our shareholders and otherwise disrupt our operations and harm our operating results.
We may in the future seek to acquire businesses, products, or technologies that we believe could complement or expand our product offerings, enhance our technical capabilities or otherwise offer growth opportunities. The pursuit of potential acquisitions may divert the attention of management and cause us to incur various expenses in identifying, investigating, and pursuing suitable acquisitions, whether or not they are consummated. If we acquire additional businesses, we may not be able to integrate the acquired personnel, operations and technologies successfully, or effectively manage the combined business following the acquisition or realize anticipated cost savings or synergies. We also may not achieve the anticipated benefits from the acquired business due to a number of factors, including:
| ● | incurrence of acquisition-related costs; |
| ● | diversion of management’s attention from other business concerns; |
| ● | unanticipated costs or liabilities associated with the acquisition; |
| ● | harm to our existing business relationships with collaboration partners as a result of the acquisition; |
| ● | harm to our brand and reputation; |
| ● | the potential loss of key employees; |
| ● | use of resources that are needed in other parts of our business; and |
| ● | use of substantial portions of our available cash to consummate the acquisition. |
In the future, if our acquisitions do not yield expected returns, we may be required to take charges to our operating results arising from the impairment assessment process. Acquisitions may also result in dilutive issuances of equity securities or the incurrence of debt, which could adversely affect our operating results. In addition, if an acquired business fails to meet our expectations, our business, results of operations and financial condition may be adversely affected.
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Risks Related to Development and Regulatory Approval of Our Product Candidates
Clinical trials for our product candidates are expensive, time-consuming, uncertain, and susceptible to change, delay or termination. The results of clinical trials are open to differing interpretations.
Clinical trials are expensive, time consuming and difficult to design and implement. Regulatory agencies may analyze or interpret the results differently than us. Even if the results of our clinical trials are favorable, the clinical trials for a number of our product candidates are expected to continue for several years and may take significantly longer to complete. In addition, we, the FDA, or other regulatory authorities, including state and local authorities, or an Institutional Review Board, or IRB, with respect to a trial at its institution, may suspend, delay or terminate our clinical trials at any time, require us to conduct additional clinical trials, require a particular clinical trial to continue for a longer duration than originally planned, require a change to our development plans such that we conduct clinical trials for a product candidate in a different order, e.g., in a step-wise fashion rather than running two trials of the same product candidate in parallel, or the DEA could suspend or terminate the registrations and quota allotments we require in order to procure and handle controlled substances, for various reasons, including:
| ● | lack of effectiveness of any product candidate during clinical trials; |
| ● | discovery of serious or unexpected toxicities or side effects experienced by trial participants or other safety issues, such as drug interactions, including those which cause confounding changes to the levels of other concomitant medications; |
| ● | slower than expected rates of subject recruitment and enrollment rates in clinical trials; |
| ● | difficulty in retaining subjects who have initiated a clinical trial but may withdraw at any time due to adverse side effects from the therapy, insufficient efficacy, fatigue with the clinical trial process or for any other reason; |
| ● | delays or inability in manufacturing or obtaining sufficient quantities of materials for use in clinical trials due to regulatory and manufacturing constraints; |
| ● | inadequacy of or changes in our manufacturing process or product formulation; |
| ● | delays in obtaining regulatory authorization to commence a trial, including “clinical holds” or delays requiring suspension or termination of a trial by a regulatory agency, such as the FDA, before or after a trial is commenced; |
| ● | changes in applicable regulatory policies and regulations, including changes to requirements imposed on the extent, nature, or timing of studies; |
| ● | delays or failure in reaching agreement on acceptable terms in clinical trial contracts or protocols with prospective clinical trial sites; |
| ● | uncertainty regarding proper dosing; |
| ● | delay or failure to supply product for use in clinical trials which conforms to regulatory specification; |
| ● | unfavorable results from ongoing pre-clinical studies and clinical trials; |
| ● | failure of our contract research organizations, or CROs, or other third-party contractors to comply with all contractual requirements or to perform their services in a timely or acceptable manner; |
| ● | failure by us, our employees, our CROs or their employees to comply with all applicable FDA or other regulatory requirements relating to the conduct of clinical trials or the handling, storage, security, and recordkeeping; |
| ● | scheduling conflicts with participating clinicians and clinical institutions; |
| ● | failure to design appropriate clinical trial protocols; |
| ● | regulatory concerns with cannabinoid products generally and the potential for abuse; |
| ● | insufficient data to support regulatory approval; |
| ● | inability or unwillingness of medical investigators to follow our clinical protocols; or |
| ● | difficulty in maintaining contact with patients during or after treatment, which may result in incomplete data. |
Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.
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Clinical trials of synthetic cannabinoid drug candidates and ketamine analogs are novel with very limited or non-existing history; we face a significant risk that the trials will not result in commercially viable drugs and treatments.
At present, there is only a very limited documented clinical trial history from which we can derive any scientific conclusions for our product candidates or prove that our present assumptions for the current and planned research are scientifically compelling. The active pharmaceutical ingredient (or API) content shown in INDs can vary from one IND to another - hence it is not necessarily possible to extrapolate results from studies with one product and predict efficacy of safety with another product containing a similar API and different source. Whilst the principal synthetic cannabinoid component may be similar, the APIs may differ in terms of minor cannabinoid content, impurity profiles or degradant profiles. While we are encouraged by the results of clinical trials by others (where they exist), there can be no assurance that any pre-clinical study or clinical trial will result in in commercially viable drugs or treatments.
Clinical trials are expensive, time consuming and difficult to design and implement. We, as well as the regulatory authorities, may suspend, delay or terminate our clinical trials at any time, may require us, for various reasons, to conduct additional clinical trials, or may require a particular clinical trial to continue for a longer duration than originally planned, including, among others:
| ● | lack of effectiveness of any API, formulation, or delivery system during clinical trials; |
| ● | discovery of serious or unexpected toxicities or side effects experienced by trial participants or other safety issues; |
| ● | slower than expected rates of subject recruitment and enrollment rates in clinical trials; |
| ● | delays or inability in manufacturing or obtaining sufficient quantities of GMP-grade materials for use in clinical trials due to regulatory and manufacturing constraints; |
| ● | delays in obtaining regulatory authorization to commence a trial, including Institutional Review Board (“IRB”) approvals or DEA approvals, licenses required for obtaining and using synthetic cannabinoids or cannabinoid-like substances for research, either before or after a trial is commenced; |
| ● | unfavorable results from ongoing pre-clinical studies and clinical trials; |
| ● | patients or investigators failing to comply with clinical trial protocols; |
| ● | patients failing to return for post-treatment follow-up at the expected rate; |
| ● | sites participating in an ongoing clinical trial withdraw, requiring us to engage new sites; |
| ● | third-party clinical investigators decline to participate in our clinical trials, do not perform the clinical trials on the anticipated schedule, or act in ways inconsistent with the established investigator agreement, clinical trial protocol, good clinical practices, and other IRB requirements; |
| ● | third-party entities do not perform data collection and analysis in a timely or accurate manner or at all; or |
| ● | regulatory inspections of our clinical trials require us to undertake corrective action or suspend or terminate our clinical trials. |
Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition.
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We are subject to federal and state healthcare laws and regulations and implementation of or changes to such healthcare laws and regulations could adversely affect our business and results of operations.
In the United States, there have been a number of legislative and regulatory proposals to change the healthcare system in ways that could impact our ability to sell our product candidates. If we are found to be in violation of any of these laws or any other federal or state regulations, we may be subject to administrative, civil and/or criminal penalties, damages, fines, individual imprisonment, exclusion from federal health care programs and the restructuring of our operations. Any of these could have a material adverse effect on our business and financial results. Since many of these laws have not been fully interpreted by the courts, there is an increased risk that we may be found in violation of one or more of their provisions. Any action against us for violation of these laws, even if we ultimately are successful in our defense, will cause us to incur significant legal expenses and divert our management’s attention away from the operation of our business.
We expect that the ACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we may receive for any approved product. There have been judicial challenges to certain aspects of the ACA and numerous legislative attempts to repeal and/or replace the ACA in whole or in part, and we expect there will be additional challenges and amendments to the ACA in the future. At this time, the full effect that the ACA will have on our business in the future remains unclear. An expansion in the government’s role in the U.S. healthcare industry may cause general downward pressure on the prices of prescription drug products, lower reimbursements, or any other product for which we obtain regulatory approval, reduce product utilization, and adversely affect our business and results of operations. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payers. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize products for which we may receive regulatory approval.
We plan to conduct clinical trials at sites outside the United States. The FDA may not accept data from trials conducted in such locations, and the conduct of trials outside the United States could subject us to additional delays and expense.
We plan to conduct one or more clinical trials with one or more trial sites that are located outside the United States. The acceptance by the FDA or other regulatory authorities of study data from clinical trials conducted outside their jurisdiction may be subject to certain conditions or may not be accepted at all. In cases where data from foreign clinical trials are intended to serve as the sole basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the United States population and United States medical practice; (ii) the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations and (iii) the data may be considered valid without the need for an on-site inspection by the FDA, or if the FDA considers such inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means.
In addition, even where the foreign study data are not intended to serve as the sole basis for approval, the FDA will not accept the data as support for an application for marketing approval unless the study is well-designed and well-conducted in accordance with GCP requirements and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary. Many foreign regulatory authorities have similar approval requirements. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from trials conducted outside of the United States or the applicable jurisdiction. If the FDA or any comparable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which could be costly and time-consuming, and which may result in current or future product candidates that we may develop not receiving approval for commercialization in the applicable jurisdiction.
Conducting clinical trials outside the United States also exposes us to additional risks, including risks associated with:
● additional foreign regulatory requirements;
● foreign exchange fluctuations;
● compliance with foreign manufacturing, customs, shipment and storage requirements;
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● cultural differences in medical practice and clinical research;
● diminished protection of intellectual property in some countries; and
● interruptions or delays in our trials resulting from geopolitical events, such as war or terrorism.
The regulatory approval processes with the FDA are lengthy and inherently unpredictable.
We are not permitted to market our drug candidates as medicines in the United States or other countries until we receive approval of a New Drug Application (“NDA”) from the FDA or in any foreign countries until we receive the approval from the regulatory authorities of such countries. Prior to submitting an NDA to the FDA for approval of our drug candidates we will need to have completed our pre-clinical studies and clinical trials and demonstrate that our products meet all applicable standards of identity, strength, quality, and purity throughout their expiration date. Successfully completing any clinical program and obtaining approval of an NDA is a complex, lengthy, expensive, and uncertain process, and the FDA (or other country medicines regulatory body) may delay, limit, or deny approval of product candidates for many reasons, including, among others, because:
| ● | an inability to demonstrate that our product candidates are safe and effective in treating patients to the satisfaction of the FDA; |
| ● | results of clinical trials that may not meet the level of statistical or clinical significance required by the FDA; |
| ● | disagreements with the FDA with respect to the number, design, size, conduct or implementation of clinical trials; |
| ● | requirements by the FDA to conduct additional clinical trials; |
| ● | disapproval by the FDA of certain formulations, labeling or specifications of product candidates; |
| ● | findings by the FDA that the data from pre-clinical studies and clinical trials are insufficient; |
| ● | findings by the FDA that our API or finished products do not meet all applicable standards of identity, strength, quality, and purity; |
| ● | the FDA may disagree with the interpretation of data from pre-clinical studies and clinical trials; and |
| ● | the FDA may change their approval policies or adopt new regulations. |
Any of these factors, many of which are beyond our control, could increase development time and / or costs or jeopardize our ability to obtain regulatory approval for our drug candidates.
There is a high rate of failure for drug candidates proceeding through clinical trials.
Generally, there is a high rate of failure for drug candidates proceeding through clinical trials. We may suffer significant setbacks in our clinical trials similar to the experience of a number of other companies in the pharmaceutical and biotechnology industries, even after receiving promising results in earlier trials. Further, even if we view the results of a clinical trial to be positive, FDA may disagree with our interpretation of the data. In the event that we obtain negative results from clinical trials for product candidates or other problems related to potential chemistry, manufacturing and control issues or other hurdles occur and our product candidates are not approved, we may not be able to generate sufficient revenue or obtain financing to continue our operations, our ability to execute on our current business plan may be materially impaired, our reputation in the industry and in the investment community might be significantly damaged and the price of our common stock could decrease significantly. In addition, our inability to properly design, commence and complete clinical trials may negatively impact the timing and results of our clinical trials and ability to seek approvals for our drug candidates.
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If we are found in violation of federal or state “fraud and abuse” laws, we may be required to pay a penalty and/or be suspended from participation in federal or state health care programs, which may adversely affect our business, financial condition, and results of operations.
In the United States, we are subject to various federal and state health care “fraud and abuse” laws, including anti-kickback laws, false claims laws and other laws intended to reduce fraud and abuse in federal and state health care programs, which could affect us particularly upon successful commercialization of our products in the U.S. The Medicare and Medicaid Patient Protection Act of 1987, or federal Anti-Kickback Statute, makes it illegal for any person, including a prescription drug manufacturer (or a party acting on its behalf), to knowingly and willfully solicit, receive, offer or pay any remuneration that is intended to induce the referral of business, including the purchase, order or prescription of a particular drug for which payment may be made under a federal health care program, such as Medicare or Medicaid. Under federal law, some arrangements, known as safe harbors, are deemed not to violate the federal Anti-Kickback Statute. Although we seek to structure our business arrangements in compliance with all applicable requirements, it is often difficult to determine precisely how the law will be applied in specific circumstances. Accordingly, it is possible that our practices may be challenged under the federal Anti-Kickback Statute and Federal False Claims Act. Violations of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including fines and/or exclusion or suspension from federal and state health care programs such as Medicare and Medicaid and debarment from contracting with the U.S. government. In addition, private individuals have the ability to bring actions on behalf of the government under the federal False Claims Act as well as under the false claims laws of several states.
Many states have adopted laws similar to the federal anti-kickback statute, some of which apply to the referral of patients for health care services reimbursed by any source, not just governmental payers. There are ambiguities as to what is required to comply with these state requirements and if we fail to comply with an applicable state law requirement, we could be subject to penalties.
Neither the government nor the courts have provided definitive guidance on the application of fraud and abuse laws to our business. Law enforcement authorities are increasingly focused on enforcing these laws, and it is possible that some of our practices may be challenged under these laws. While we believe we have structured our business arrangements to comply with these laws, it is possible that the government could allege violations of, or convict us of violating, these laws. If we are found in violation of one of these laws, we could be required to pay a penalty and could be suspended or excluded from participation in federal or state health care programs, and our business, results of operations and financial condition may be adversely affected.
Serious adverse events or other safety risks could require us to abandon development and preclude, delay or limit approval of our product candidates, limit the scope of any approved label or market acceptance, or cause the recall or loss of marketing approval of products that are already marketed.
If any of our product candidates prior to or after any approval for commercial sale, cause serious or unexpected side effects, or are associated with other safety risks such as misuse, abuse or diversion, a number of potentially significant negative consequences could result, including:
| ● | regulatory authorities may interrupt, delay or halt clinical trials; |
| ● | regulatory authorities may deny regulatory approval of our product candidates; |
| ● | regulatory authorities may require certain labeling statements, such as warnings or contraindications or limitations on the indications for use, and/or impose restrictions on distribution in the form of a REMS in connection with approval or post-approval; |
| ● | regulatory authorities may withdraw their approval, require more onerous labeling statements, impose a more restrictive Risk Evaluation and Mitigation Strategy (“REMS”), or require us to recall any product that is approved; |
| ● | we may be required to change the way the product is administered or conduct additional clinical trials; |
| ● | our relationships with our collaboration partners may suffer; |
| ● | we could be sued and held liable for harm caused to patients; or |
| ● | our reputation may suffer. The reputational risk is heightened with respect to those of our product candidates that are being developed for pediatric indications. |
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We may voluntarily suspend or terminate our clinical trials if at any time we believe that they present an unacceptable risk to participants or if preliminary data demonstrate that our product candidates are unlikely to receive regulatory approval or unlikely to be successfully commercialized. Following receipt of approval for commercial sale of a product we may voluntarily withdraw or recall that product from the market if at any time we believe that its use, or a person’s exposure to it, may cause adverse health consequences or death. To date we have not withdrawn, recalled, or taken any other action, voluntary or mandatory, to remove an approved product from the market. In addition, regulatory agencies, IRBs, or data safety monitoring boards may at any time recommend the temporary or permanent discontinuation of our clinical trials or request that we cease using investigators in the clinical trials if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements, or that they present an unacceptable safety risk to participants. Although we have never been asked by a regulatory agency, IRB, or data safety monitoring board to discontinue a clinical trial temporarily or permanently, if we elect or are forced to suspend or terminate a clinical trial of any of our product candidates, the commercial prospects for that product will be harmed and our ability to generate product revenue from that product may be delayed or eliminated. Furthermore, any of these events may result in labeling statements such as warnings or contraindications. In addition, such events or labeling could prevent us or our partners from achieving or maintaining market acceptance of the affected product and could substantially increase the costs of commercializing our product candidates and impair our ability to generate revenue from the commercialization of these products either by us or by our collaboration partners.
Risks Related to Our Reliance Upon Third Parties
Our existing collaboration arrangements and any that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our product candidates.
We may seek additional collaboration arrangements with pharmaceutical or biotechnology companies for the development or commercialization of our product candidates. We may, with respect to our product candidates, enter into new arrangements on a selective basis depending on the merits of retaining commercialization rights for ourselves as compared to entering into selective collaboration arrangements with leading pharmaceutical or biotechnology companies for each product candidate, both in the U.S. and internationally. To the extent that we decide to enter into collaboration agreements, we will face significant competition in seeking appropriate collaborators and the terms of any collaboration or other arrangements that we may establish may not be favorable to us.
Any existing or future collaboration that we enter may not be successful. The success of our collaboration arrangements will depend heavily on the efforts and activities of our collaborators. Collaborators generally have significant discretion in determining the efforts and resources that they will apply to these collaborations. Disagreements between parties to a collaboration arrangement regarding development, intellectual property, regulatory or commercialization matters can lead to delays in the development process or commercialization of the applicable product candidate and, in some cases, termination of the collaboration arrangement. These disagreements can be difficult to resolve if neither of the parties has final decision-making authority. Any such termination or expiration could harm our business reputation and may adversely affect us financially.
We depend on a limited number of suppliers for materials and components required to manufacture our product candidates. The loss of these suppliers, or their failure to supply us on a timely basis, could cause delays in our current and future capacity and adversely affect our business.
We depend on a limited number of suppliers for the materials and components required to manufacture our product candidates. As a result, we may not be able to obtain sufficient quantities of critical materials and components in the future. A delay or interruption by our suppliers may also harm our business, results of operations and financial condition. In addition, the lead time needed to establish a relationship with a new supplier can be lengthy, and we may experience delays in meeting demand in the event we must switch to a new supplier. The time and effort to qualify for and, in some cases, obtain regulatory approval for a new supplier could result in additional costs, diversion of resources or reduced manufacturing yields, any of which would negatively impact our operating results. Our dependence on single-source suppliers exposes us to numerous risks, including the following: our suppliers may cease or reduce production or deliveries, raise prices or renegotiate terms; our suppliers may become insolvent or cease trading; we may be unable to locate a suitable replacement supplier on acceptable terms or on a timely basis, or at all; and delays caused by supply issues may harm our reputation, frustrate our customers and cause them to turn to our competitors for future needs.
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We rely on, and expect to continue to rely on, third parties to conduct clinical trials for our product candidates. If these third parties do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain marketing approval for or commercialize our product candidates, and our business could be substantially harmed.
We have agreements with third-party CROs to operationalize, provide monitors for and to manage data for our ongoing clinical trials. We rely heavily on these parties for the execution of clinical trials and control only certain aspects of their activities. As a result, we have less direct control over the start-up, conduct, timing and competition of these clinical trials, and the management of data developed through the clinical trials than would be the case if we were relying entirely upon our own staff. Communicating with outside parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities. However, we remain responsible for the conduct of these trials and are subject to enforcement which may include civil and criminal liabilities for any violations of FDA rules and regulations and the comparable foreign regulatory provisions during the conduct of our clinical trials. Outside parties may:
| ● | have staffing difficulties; |
| ● | fail to comply with contractual obligations; |
| ● | Devote inadequate resources to our clinical trials; |
| ● | Experience regulatory compliance issues; |
| ● | Undergo changes in priorities or become financially distressed; or |
| ● | Form more favorable relationships with other entities, some of which may be our competitors. |
These factors, among others, may materially adversely affect the willingness or ability of third parties to conduct our clinical trials and may subject us to unexpected cost increases that are beyond our control. Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on CROs does not relieve us of our regulatory responsibilities. We and our CROs are required to comply with GCPs, which are guidelines enforced by the FDA, the competent authorities of the EU member states and equivalent competent authorities in foreign jurisdictions for any products in clinical development. The FDA and foreign regulatory authorities enforce these regulations and GCP guidelines through periodic inspections of clinical trial sponsors principal investigators, and trial sites, and IRBs. If we or our CROs fail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or other equivalent competent authorities in foreign jurisdictions may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that, upon inspection, the FDA or foreign regulatory authorities will determine that any of our clinical trials comply with GCPs. In addition, our clinical trials must be conducted with products produced under current Good Manufacturing Practices, or cGMPs and similar foreign requirements. Our failure or the failure of our CROs to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process and could also subject us to enforcement action up to and including civil and criminal penalties.
If any of our relationships with these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain are compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, any such clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize, Ketamir-2, MIRA-55 or our other product candidates. As a result, our financial results and the commercial prospects for Ketamir-2 MIRA-55 or our other product candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed.
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We rely and expect to continue to rely on third parties to manufacture our clinical product supplies and clinical candidates, and we may rely on third parties for at least a portion of the manufacturing process of our product candidates, if approved. Our business could be harmed if those third parties fail to provide us with sufficient quantities of product supplies or product candidates or fail to do so at acceptable quality levels or prices.
We do not currently own any facility that may be used as a clinical-scale manufacturing and processing facility, and we rely on outside vendors and collaborators to manufacture supplies and process our product candidates. For certain of our components or product candidates, we rely on single suppliers or manufacturers to supply or manufacture, but we plan to expand the number of suppliers and manufacturers as we advance our product candidates through clinical development. Our product candidates are not yet manufactured or processed on a commercial scale and we may remain unable to do so for any of our product candidates. Although in the future we may develop our own manufacturing facilities, we may also continue to use third parties as part of our manufacturing processes and may, in any event, never be successful in developing our own manufacturing facilities. Our anticipated reliance on third-party manufacturers exposes us to the following risks:
| ● | We may be unable to identify manufacturers on acceptable terms or at all because the number of potential manufacturers is limited and the FDA must inspect any manufacturers for current cGMP. |
| ● | Non-compliance of our third-party manufacturers with requirements of our marketing application(s). In addition, a new manufacturer would have to be educated in, or develop substantially equivalent processes for, the production of our product candidates. |
| ● | Third-party manufacturers may have little or no experience with our product candidates and therefore may require a significant amount of support from us in order to implement and maintain the infrastructure and processes required to manufacture our product candidates. |
| ● | Third-party manufacturers might be unable to timely manufacture our product candidates or produce the quantity and quality required to meet our clinical and commercial needs, if any. |
| ● | Third-party manufacturers may not be able to execute our manufacturing procedures and other logistical support requirements appropriately. |
| ● | Third-party manufacturers may not perform as agreed, may not devote sufficient resources to our product candidates or may not remain in the contract manufacturing business for the time required to supply our clinical trials or to successfully produce, store, and distribute our products, if any. |
| ● | Manufacturers are subject to ongoing periodic unannounced inspection by the FDA and corresponding state or foreign agencies to ensure strict compliance with cGMP and other government regulations and corresponding foreign standards. We do not have control over third-party manufacturers’ compliance with these regulations and standards. |
| ● | We may not own, or may have to share, the intellectual property rights to any improvements made by our third-party manufacturers in the manufacturing processes for our product candidates. |
| ● | Our third-party manufacturers could breach or terminate their agreements with us, and we may be required to pay fees upon suspension or termination of the agreement even if the manufacturers do not deliver adequate supply of the product candidates or their components. |
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| ● | Raw materials and components used in the manufacturing processes, particularly those for which we have no other source or supplier, may not be available or may not be suitable or acceptable for use due to factors beyond our control. |
| ● | Our third-party manufacturers may have unacceptable or inconsistent product quality success rates and yields, and we have no direct control over their ability to maintain adequate quality control, quality assurance and qualified personnel. |
Each of these risks could delay or prevent the completion of our clinical trials or the approval of any of our product candidates by the FDA, result in higher costs or adversely impact commercialization of our product candidates. In addition, we will rely on third parties to perform certain specification tests on our product candidates prior to delivery to patients. If these tests are not appropriately done and test data are not reliable, patients could be put at risk of serious harm and the FDA could place significant restrictions on our company until deficiencies are remedied. Furthermore, our or a third party’s failure to execute on our manufacturing requirements, to do so on commercially reasonable terms or to comply with cGMP could adversely affect our business in a number of ways, including:
| ● | An inability to initiate or continue clinical trials of our product candidates under development; |
| ● | Delay in submitting regulatory applications, or receiving marketing approvals, for our product candidates; |
| ● | Loss of the cooperation of future collaborators; |
| ● | Subjecting third-party manufacturing facilities or our manufacturing facilities to additional inspections by regulatory authorities; |
| ● | Requirements to cease development or to recall batches of our product candidates; and |
| ● | In the event of approval to market and commercialize our product candidates, an inability to meet commercial demands for our product or any other future product candidates. |
If any CMO or CDMO with whom we contract fails to perform its obligations, we may be forced to enter into an agreement with a different CMO or CDMO, which we may not be able to do on reasonable terms, if at all. In such scenario, our clinical trials supply could be delayed significantly as we establish alternative supply sources. In some cases, the technical skills required to manufacture our products or product candidates may be unique or proprietary to the original CMO or CDMO and we may have difficulty, or there may be contractual restrictions prohibiting us from, transferring such skills to a back-up or alternate supplier, or we may be unable to transfer such skills at all. In addition, if we are required to change CMOs or CDMOs for any reason, we will be required to verify that the new CMO or CDMO maintains facilities and procedures that comply with quality standards and with all applicable regulations. We will also need to verify, such as through a manufacturing comparability study, that any new manufacturing process will produce our product candidate according to the specifications previously submitted to the FDA or another regulatory authority. The delays associated with the verification of a new CMO or CDMO could negatively affect our ability to develop product candidates or commercialize our products in a timely manner or within budget. In addition, changes in manufacturers often involve changes in manufacturing procedures and processes, which could require that we conduct bridging studies between our prior clinical supply used in our clinical trials and that of any new manufacturer. We may be unsuccessful in demonstrating the comparability of clinical supplies which could require the conduct of additional clinical trials.
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We rely on, and expect to continue to rely on, third parties to conduct clinical trials for our product candidates. If these third parties do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain marketing approval for or commercialize our product candidates, and our business could be substantially harmed.
We are dependent on third parties to conduct our clinical trials and preclinical and nonclinical studies. Specifically, we rely on, and intend to continue to rely on, medical institutions, clinical investigators, contract research organizations, or CROs, and consultants to conduct nonclinical studies and clinical trials, in each case in accordance with our study protocols and applicable regulatory requirements. These CROs, investigators and other third parties play a significant role in the conduct and timing of these studies or trials and the subsequent collection and analysis of data. Though we expect to carefully manage our relationships with our CROs, investigators and other third parties, there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects. Further, while we have and will have agreements governing the activities of our third-party contractors, we have limited influence over their actual performance. Nevertheless, we are responsible for ensuring that each of our clinical trials is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards and requirements, and our reliance on our CROs and other third parties does not relieve us of our regulatory responsibilities. In addition, we and our CROs are required to comply with GLP and GCP requirements, as applicable, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities related to the conduct of nonclinical studies and clinical trials, respectively. Regulatory authorities enforce GCPs through periodic inspections of trial sponsors, principal investigators and trial sites. If we or any of our CROs or trial sites fail to comply with applicable GLP or GCP or other requirements, the collected nonclinical data or the clinical data generated in our clinical trials may be deemed unreliable, and the FDA or comparable foreign regulatory authorities may require us to perform additional nonclinical studies or clinical trials before approving our marketing applications, if ever. Furthermore, our clinical trials must be conducted with materials manufactured in accordance with cGMP regulations. Failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process.
There is a risk that our CROs, investigators or other third parties will be unable to devote adequate time and resources to such trials or studies or perform as contractually required. If any of these third parties fail to meet expected deadlines, adhere to our clinical protocols or meet regulatory requirements, or otherwise perform in a substandard manner, our clinical trials may be extended, delayed or terminated. In addition, many of the third parties with whom we contract may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other development activities that could harm our competitive position. In addition, principal investigators for our clinical trials are expected to serve as scientific advisors or consultants to us from time to time and may receive cash or equity compensation in connection with such services. If these relationships and any related compensation result in perceived or actual conflicts of interest, or the FDA concludes that the financial relationship may have affected the interpretation of the study, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical trial itself may be jeopardized, which could result in the delay or rejection by the FDA of any NDA we submit. Any such delay or rejection could prevent us from receiving regulatory approval for, or commercializing, TELOIR-1 and any future product candidates.
Our CROs have the right to terminate their agreements with us in the event of an uncured material breach and under other specified circumstances. If any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative third parties on commercially reasonable terms, in a timely manner or at all. Switching or adding CROs, investigators and other third parties involves additional cost and requires our management’s time and focus. In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. Though we work to carefully manage our relationships with our CROs, investigators and other third parties, there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.
Risks Related to Our Intellectual Property
We may not be able to adequately protect our product candidates or our proprietary technology in the marketplace.
Our success will depend, in part, on our ability to obtain patents, protect our trade secrets and operate without infringing on the proprietary rights of others. We may rely upon a combination of patents, trade secret protection (i.e., know-how), trademarks, licenses, and confidentiality agreements to protect the intellectual property of our product candidates. The strengths of patents in the pharmaceutical field involve complex legal and scientific questions and can be uncertain. Where appropriate, we seek patent protection for certain aspects of our products and technology. However, patent protection for naturally occurring compounds is exceedingly difficult to obtain, defend and enforce. Filing, prosecuting and defending patents throughout the world would be prohibitively expensive, so our policy is to look to patent technologies with commercial potential in jurisdictions with significant commercial opportunities. However, patent protection may not be available for some of the products or technology we are developing. If we must spend significant time and money protecting, defending, or enforcing our patents, designing around patents held by others or licensing, potentially for large fees, patents or other proprietary rights held by others, our business, results of operations and financial condition may be harmed. We may not develop additional proprietary products that are patentable.
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The patent positions of pharmaceutical products are complex and uncertain. The scope and extent of patent protection for our product candidates are particularly uncertain. To date, our principal product candidates have been based on specific formulations of certain previously known cannabinoids found in nature in the cannabis sativa plant. While we have sought patent protection, where appropriate, directed to, among other things, composition-of-matter for our specific formulations, their methods of use, and methods of manufacture, we do not have and will not be able to obtain composition of matter protection on these previously known cannabinoids per se. We anticipate that the products we develop in the future will continue to be based on the same or other naturally occurring compounds, as well as additional synthetic compounds we may discover. Although we have sought and expect to continue to seek patent protection for our product candidates, their methods of use, and methods of manufacture, any, or all of them may not be subject to effective patent protection. If any of our products are approved and marketed for an indication for which we do not have an issued patent, our ability to use our patents to prevent a competitor from commercializing a non-branded version of our commercial products for that non-patented indication could be significantly impaired or even eliminated.
Publication of information related to our product candidates by us, or others may prevent us from obtaining or enforcing patents relating to these products and product candidates. Furthermore, others may independently develop similar products, may duplicate our products, or may design around our patent rights. In addition, any of our issued patents may be opposed and/or declared invalid or unenforceable. If we fail to adequately protect our intellectual property, we may face competition from companies who attempt to create a generic product to compete with our product candidates. We may also face competition from companies who develop a substantially similar product to one of our product candidates that is not covered by any of our patents.
If third parties claim that our intellectual property, products, processes, or anything else used by us infringes upon their intellectual property, our operating profits could be adversely affected.
There is a substantial amount of litigation, both within and outside the U.S., involving patent and other intellectual property rights in the pharmaceutical industry. We may, from time to time, be notified of claims that we are infringing upon patents, trademarks, copyrights, or other intellectual property rights owned by third parties, and we cannot provide assurances that other companies will not, in the future, pursue such infringement claims against us, our commercial partners or any third-party proprietary technologies we have licensed. If we were found to infringe upon a patent or other intellectual property right, or if we failed to obtain or renew a license under a patent or other intellectual property right from a third party, or if a third party that we were licensing technologies from was found to infringe upon a patent or other intellectual property rights of another third party, we may be required to pay damages, including damages of up to three times the damages found or assessed, if the infringement is found to be willful, suspend the manufacture of certain products or reengineer or rebrand our products, if feasible, or we may be unable to enter certain new product markets. Any such claims could also be expensive and time-consuming to defend and divert management’s attention and resources. Our competitive position could suffer as a result. In addition, if we have declined or failed to enter into a valid non-disclosure or assignment agreement for any reason, we may not own the invention or our intellectual property, and our products may not be adequately protected. Thus, we cannot guarantee that our product candidates, or our commercialization thereof, does not and will not infringe any third party’s intellectual property.
If we are unable to obtain and maintain intellectual property protection for our technology and products, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be impaired.
Our success depends in large part on our ability to obtain and maintain patent protection in relevant countries with respect to our proprietary technology and products. We seek to protect our proprietary position by filing patent applications in the United States and internationally that are related to our novel technologies and product candidates. This patent portfolio includes issued patents and pending patent applications covering pharmaceutical compositions and methods of use.
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The patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. We may choose not to seek patent protection for certain innovations and may choose not to pursue patent protection in certain jurisdictions, and under the laws of certain jurisdictions, patents or other intellectual property rights may be unavailable or limited in scope. It is also possible that we will fail to identify patentable aspects of our discovery and nonclinical development output before it is too late to obtain patent protection. Moreover, in some circumstances, we may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology that we license from third parties. Therefore, these patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business.
The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States. For example, India and China do not allow patents for methods of treating the human body. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we were the first to file for patent protection of such inventions. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Our pending and future patent applications may not result in patents being issued which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the EU, the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection.
The risks described pertaining to our patents and other intellectual property rights also apply to the intellectual property rights that we license, and any failure to obtain, maintain and enforce these rights could have a material adverse effect on our business. In some cases, we may not have control over the prosecution, maintenance or enforcement of the patents that we license, and our licensors may fail to take the steps that we believe are necessary or desirable in order to obtain, maintain and enforce the licensed patents. Any inability on our part to protect adequately our intellectual property may have a material adverse effect on our business, operating results and financial position.
The USPTO and various non-U.S. governmental patent agencies require compliance with several procedural, documentary, fee payment and other similar provisions during the patent application process. In certain situations, non-compliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, our competitors might be able to enter the market, and this circumstance would have a material adverse effect on our business.
In addition, we acquired rights to Ketomir-2 through a license agreement with MIRALOGX and may in the future enter into other license agreements with third parties for other intellectual property rights or assets. These license agreements may impose various diligence, milestone payment, royalty, and other obligations on us. If we fail to comply with our obligations under these agreements, or we are subject to a bankruptcy, we may be required to make certain payments to the licensor, we may lose the exclusivity of our license, or the licensor may have the right to terminate the license, in which event we would not be able to develop or market products covered by the license. Additionally, the milestone and other payments associated with these licenses will make it less profitable for us to develop our drug candidates than if we had developed the licensed technology internally.
In some cases, patent prosecution of our licensed technology may be controlled solely by the licensor. If our licensors fail to obtain and maintain patent or other protection for the proprietary intellectual property we license from them, we could lose our rights to the intellectual property or our exclusivity with respect to those rights, and our competitors could market competing products using the intellectual property. In certain cases, we may control the prosecution of patents resulting from licensed technology. In the event we breach any of our obligations related to such prosecution, we may incur significant liability to our licensing partners. If disputes over intellectual property and other rights that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates.
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We have no patent protection for MIRA-55, which could adversely impact MIRA-55’s potential competitive position.
We have no issued patents relating to MIRA-55 and our patent application for MIRA-55 may not result in an issued patent. While we attempt to protect our proprietary information as trade secrets through certain agreements with our employees, consultants, agents and other organizations to which we disclose our proprietary information, we cannot give assurance that these agreements will provide effective protection for our proprietary information in the event of unauthorized use or disclosure of such information. If other products similar to MIRA-55 are approved and marketed, we may be unable to prevent them from competing with MIRA-55 in MIRA-55’s potential marketplace. We expect that the presence of one or more competing products could reduce our potential market share and could negatively impact potential price levels and third-party reimbursement for MIRA-55, any of which would materially affect our business.
Risks Related to SKNY and SKNY-1
SKNY has yet to generate revenues or achieve a profit and may not generate revenue or achieve a profit for many years, if at all.
SKNY has not yet produced any revenues or profit and may not for many years, if at all. SKNY’s ability to generate revenue is dependent on the receipt of regulatory approval of SKNY’s product candidates, which will take years to achieve and may not be obtained. MIRA therefore cannot assure you SKNY will be able to ever generate sufficient revenue to pay for SKNY’s expenses or achieve profitability. SKNY’s ability to continue as a going concern in the future is dependent upon raising capital from financing transactions and keeping operating expenses below SKNY’s revenue levels in order to achieve positive cash flows, none of which can be assured.
SKNY does not own rights to SKNY-1.
All of SKNY’s rights in SKNY-1 are granted to it under a license (“License”) from MIRALOGIX LLC, a Florida corporation (“Licensor”), so SKNY does not have an ownership interest in SKNY-1. The License give SKNY the right to make, use and sell SKNY-1 only in the US, Canada, and Mexico. The Licensor retained the rights to SKNY-1 everywhere outside of the US, Canada and Mexico. If SKNY breaches the License or if the Licensor goes bankrupt, SKNY could lose its rights to SKNY-1 and all of such rights would revert back to the Licensor. Further, Licensor will control the process of applying for and obtaining any patents or other intellectual property rights in SKNY-1, all at the expense of SKNY. All of such patents and intellectual rights will be owned by Licensor, subject to SKNY’s rights under the License. Furthermore, SKNY has no control over the patent prosecution strategy, which is fully managed by the Licensor.
SKNY’s rights to SKNY-1 are subject to royalties.
SKNY entered into an exclusive licensing agreement with MIRALOGIX LLC, a Florida corporation (“MIRALOGIX”) for the licensing by MIRALOGX to SKNY the commercial rights of SKNY-1, or M308 (the “SKNY-1 Licensing Agreement”) in the United States, Mexico and Canada. Under the SKNY-1 Licensing Agreement SKNY will owe MIRALOGX a royalty of 8% on all revenue it receives from SKNY-1, with a minimum annual royalty of $250,000 that begins in the first year that there is any revenue from SKNY-1. This $250,000 will be owed even if in any later year there is no revenue from SKNY-1 or if the 8% royalty rate on actual revenues yields less than $250,000. SKNY’s failure to pay minimum royalties in any year would be a breach of the SKNY-1 Licensing Agreement and such breach would let the Licensor terminate SKNY’s rights to SKNY-1.
Conflicts of interest may arise between SKNY and MIRALOGX.
MIRALOGX is the license of SKNY’s rights to SKNY-1. MIRALOGX is a separate intellectual property development company owned by the Bay Shore Trust. The Bay Shore Trust is also SKNY’s largest stockholder. MIRALOGX is 100% owned by the Bay Shore Trust. SKNY’s relationship with MIRALOGX and the Bay Shore Trust may create, or may create the appearance of, conflicts of interest when SKNY is faced with decisions that benefit MIRALOGIX but do not benefit other holders of MIRA Common Stock. Furthermore, in light of the license agreement that SKNY has with MIRALOGX, if a dispute were to arise between MIRALOGX and MIRA relating to SKNY’s past or future relationship with MIRALOGX or with respect to intellectual property matters, there could be a conflict of interest that may make it more difficult for SKNY to resolve such disputes on terms that are acceptable to SKNY.
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SKNY’s product candidates, if approved, may not achieve the expected market acceptance and, consequently, limit SKNY’s ability to generate revenue.
Even when product development is successful and regulatory approval has been obtained, SKNY’s ability to generate sufficient revenue depends on the acceptance of its products by physicians and patients. There is no assurance that SKNY’s product candidates will achieve the expected level of market acceptance and revenue if and when they obtain the requisite regulatory approvals. The market acceptance of any product depends on a number of factors, including the indication statement and warnings required by regulatory authorities in the product label. Market acceptance can also be influenced by continued demonstrations of efficacy and safety in commercial use, physicians’ willingness to prescribe the product, reimbursement from third-party payers such as government health care programs and private third-party payers, the price of the product, the nature of any post-approval risk management activities mandated by regulatory authorities, competition, and marketing and distribution support. Further, an ineffective or inefficient distribution model at launch may lead to the inability to fulfill demand, and consequently a loss of revenue. Any factors preventing or limiting the market acceptance of SKNY’s products could have a material adverse effect on SKNY’s business, results of operations and financial condition.
SKNY expects to face intense competition, often from companies with greater resources and experience than it has.
Demand for SKNY’s product candidates will likely be dependent on a number of social, political, legislative, and economic factors that are beyond its control. While we believe that there will be a demand for such drugs, and that the demand will grow, there is no assurance that such demand will happen, that we will benefit from any demand or that its business, in fact, will ever generate revenues from its drug development programs or become profitable.
The emerging markets for product candidates like SKNY’s and related medical research and development is and will likely remain competitive. The development and commercialization of drugs and medicines is highly competitive. SKNY competes with a variety of multinational pharmaceutical companies and specialized biotechnology companies, as well as products and processes being developed by universities and other research institutions. Many of SKNY’s competitors have developed, are developing, or will develop drugs and processes which may be competitive with SKNY’s drug candidates. Competitive therapeutic treatments include those that have already been approved by medicines regulators and accepted by the medical community and any new treatments that may enter the market. For some of SKNY’s drug development programs / areas of therapeutic interest, other treatment options are currently available, under development, and may become commercially available in the future. If any of SKNY’s product candidates are approved for the diseases and conditions SKNY is currently pursuing, they may compete with a range of medicines or therapeutic treatments that are either in development, will be developed in the future or currently marketed.
Established companies may have a competitive advantage over SKNY due to their size and experiences, financial resources, and institutional networks. Many of SKNY’s competitors may have significantly greater financial, technical, and human resources than SKNY does. Due to these factors, SKNY’s competitors may have an advantage in marketing their approved drugs and may obtain regulatory approval of their drug candidates before SKNY is able to, which may limit its ability to develop or commercialize SKNY’s drug candidates. SKNY’s competitors may also develop drugs / medicines that are safer, more effective, more widely used and less expensive than SKNY’s. These advantages could materially impact SKNY’s ability to develop and, if approved, commercialize SKNY’s product candidates successfully. Furthermore, some of these competitors may make acquisitions or establish collaborative relationships among themselves or with third parties to increase their ability to rapidly gain market share.
Moreover, as generic versions of drug products enter the market, the price for such medicines may be expected to decline rapidly and substantially. Even if SKNY-1 is the first to obtain FDA approval of one of its product candidates, the future potential approval of generics could adversely affect the price SKNY is able to charge, and the profitability of SKNY’s product(s) will likely decline.
Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in more resources being concentrated among a smaller number of SKNY’s competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.
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These companies may compete with SKNY in recruiting and retaining qualified scientific, management and commercial personnel, utilizing contract manufacturing facilities or contract research organizations (CROs), or establishing clinical trial sites and subject registration for clinical trials, as well as in acquiring technologies complementary to SKNY’s research projects.
We are dependent on SKNY’s current and future product candidates, some of which may not receive regulatory approval or be successfully commercialized.
Our ability to progress SKNY’s plan will depend on SKNY’s ability to clinically develop, gain regulatory approval for and ultimately commercialize SKNY’s product candidates. SKNY’s ability to successfully commercialize SKNY’s product candidates will depend on, among other things, SKNY’s ability to:
| ● | successfully complete pre-clinical and other nonclinical studies and clinical trials in a manner that allows us to progress SKNY’s studies; | |
| ● | receive IND acceptance and regulatory approvals from the FDA; | |
| ● | produce, through a validated process, in manufacturing facilities inspected and approved by regulatory authorities, including the FDA, sufficiently large quantities of product candidates to permit successful commercialization; | |
| ● | obtain reimbursement from payers such as government health care programs and insurance companies and achieve commercially attractive levels of pricing; | |
| ● | secure acceptance of SKNY’s product candidates from physicians, health care payers, patients, and the medical community; | |
| ● | create positive publicity surrounding SKNY’s product candidates; | |
| ● | manage SKNY’s spending as costs and expenses increase due to clinical trials and commercialization; and | |
| ● | obtain and enforce sufficient intellectual property rights for SKNY’s product candidates. |
SKNY’s failure or delay with respect to any of the factors above could have a material adverse effect on SKNY’s business, results of operations and financial condition.
Risks Relating to the Ownership of our Common Stock
Because of the speculative nature of investment risk, you may lose your entire investment.
An investment in our securities carries a high degree of risk and should be considered as a speculative investment. We have a limited operating history, no revenues, have not paid dividends, and are unlikely to pay dividends in the immediate or near future. The likelihood of our success must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered in connection with the establishment of any business. An investment in our securities may result in the loss of an investor’s entire investment. Only potential investors who are experienced in high-risk investments and who can afford to lose their entire investment should consider an investment in our securities.
Certain of our founding stockholders, plus our existing officers and directors, control a substantial interest in us and thus may influence certain actions requiring stockholder vote.
Our founding stockholders, which include the Bay Shore Trust, and MIRALOGX, collectively own in excess of 27% of our issued and outstanding common stock, as well as outstanding warrants. Our officers and directors also own shares of our common stock. Therefore, these entities and individuals could influence the outcome of matters requiring stockholder approval, including the election of directors and approval of significant corporate transactions.
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Sales of a significant number of shares of our common stock in the public markets, or the perception that such sales could occur, could depress the market price of our common stock.
Sales of a significant number of shares of our common stock in the public markets, or the perception that such sales could occur as a result of our utilization of a universal shelf registration statement or otherwise could depress the market price of our common stock and impair our ability to raise capital through the sale of additional equity securities. Notably, a large number of shares of our common stock held by Bay Shore Trust and MIRALOGX have been registered for public resale and could be sold in the public market, depressing our stock price. Moreover, we cannot in general predict the effect that future sales of our common stock or the market perception that we are permitted to sell a significant number of our securities would have on the market price of our common stock.
The requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain executive management and qualified board members.
As a reporting issuer, we are subject to the reporting requirements of applicable securities legislation of the jurisdiction in which we are a reporting issuer, the listing requirements of Nasdaq and other applicable securities rules and regulations. Compliance with these rules and regulations increase our legal and financial compliance costs, make some activities more difficult, time-consuming or costly and increase demand on its systems and resources. Applicable securities laws require us to, among other things, file certain annual and quarterly reports with respect to its business and results of operations. In addition, applicable securities laws require us to, among other things, maintain effective disclosure controls and procedures and internal control over financial reporting.
In order to maintain and, if required, improve its disclosure controls and procedures and internal control over financial reporting to meet this standard, significant resources and management oversight are required and, as a result, management’s attention may be diverted from other business concerns, which could harm our business and results of operations. To comply with these requirements, we may need to hire more employees in the future or engage outside consultants, which will increase our costs and expenses.
In addition, changing laws, regulations and standards relating to corporate governance and public disclosure are creating uncertainty for public companies, increasing legal and financial compliance costs and making some activities more time consuming. These laws, regulations and standards are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. We intend to continue to invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased general and administrative expenses and a diversion of management’s time and attention from revenue-generating activities to compliance activities. If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to their application and practice, regulatory authorities may initiate legal proceedings against us, which could adversely affect our business and financial results.
As a public company subject to these rules and regulations, it may be more expensive to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These factors could also make it more difficult for us to attract and retain qualified members of the Board, particularly to serve on the Audit Committee and Compensation Committee, and qualified executive officers.
We are an “emerging growth company,” and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to emerging growth companies could make shares of our common stock less attractive to investors.
We are an “emerging growth company,” as defined in Section 2(a) of the Securities Act. For as long as we continue to be an emerging growth company, we may choose to take advantage of exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies, including, but not limited to, not being required to have our independent registered public accounting firm audit our internal control over financial reporting under Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved. We could be an emerging growth company until the fifth anniversary of the fiscal year end date following the completion of our initial public offering, however, our status would change more quickly if we have more than US$1.235 billion in annual revenue, if the market value of our shares of common stock held by non-affiliates equals or exceeds US$700 million as of June 30 of any year, or we issue more than US$1.0 billion of non-convertible debt over a three-year period before the end of that period.
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Investors could find our shares less attractive if we choose to rely on these exemptions. If some investors find shares less attractive as a result of any choice to reduce future disclosure, there may be a less active trading market for our shares and our share price may be more volatile.
For as long as we are an “emerging growth company”, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal controls over financial reporting pursuant to Section 404. We could be an “emerging growth company” until the fifth anniversary of the fiscal year end date following the completion of our initial public offering. An independent assessment of the effectiveness of our internal controls could detect problems that our management’s assessment might not. Undetected material weaknesses in our internal controls could lead to financial statement restatements and require us to incur the expense of remediation.
If we identify material weaknesses in our internal control over financial reporting, or if we are unable to comply with the requirements of Section 404 in a timely manner or assert that our internal control over financial reporting is effective, or if our independent registered public accounting firm is unable to express an opinion as to the effectiveness of our internal control over financial reporting when required, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our securities could be negatively affected, and we could become subject to investigations by the stock exchange on which our securities are listed, the SEC, or other regulatory authorities, which could require additional financial and management resources.
Additionally, we are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company until the last day of any fiscal year for so long as either: (i) the market value of our shares of common stock held by non-affiliates does not equal or exceed $250 million as of the prior June 30th; or (ii) our annual revenues did not equal or exceed $100 million during such completed fiscal year. To the extent we take advantage of such reduced disclosure obligations, it may also make the comparison of our financial statements with other public companies difficult or impossible.
If we fail to maintain compliance with Nasdaq Listing Rules, our shares may be delisted from Nasdaq, which would result in a limited trading market for our shares and make obtaining future debt or equity financing more difficult for the us.
Our common stock is listed on the Nasdaq Capital Market under the symbol “MIRA”. However, there is no assurance that we will be able to continue to maintain our compliance with the Nasdaq continued listing requirements. If we fail to do so, our securities may lose their status on Nasdaq and they would likely be traded on the over-the-counter markets, including the Pink Sheets market. As a result, selling our securities could be more difficult because smaller quantities of shares or warrants would likely be bought and sold, transactions could be delayed, and security analysts’ coverage of us may be reduced. In addition, in the event our securities are delisted, broker dealers would bear certain regulatory burdens which may discourage broker dealers from effecting transactions in the securities and further limit the liquidity of the securities. These factors could result in lower prices and larger spreads in the bid and ask prices for the securities. Such delisting from Nasdaq and continued or further declines in the share price of the securities could also greatly impair our ability to raise additional necessary capital through equity or debt financing and could significantly increase the ownership dilution to shareholders caused by our issuing equity in financing or other transactions.
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If our shares were to be delisted from Nasdaq, they may become subject to the SEC’s “penny stock” rules.
Delisting from Nasdaq may cause our securities to become subject to the SEC’s “penny stock” rules. The SEC generally defines a penny stock as an equity security that has a market price of less than $5.00 per share or an exercise price of less than $5.00 per share, subject to certain exemptions. One such exemption is to be listed on Nasdaq. Therefore, if shares of our common stock were to be delisted from Nasdaq, our securities could become subject to the SEC’s “penny stock” rules. These rules require, among other things, that any broker engaging in a purchase or sale of our securities provide its customers with: (i) a risk disclosure document, (ii) disclosure of market quotations, if any, (iii) disclosure of the compensation of the broker and its salespersons in the transaction, and (iv) monthly account statements showing the market values of our securities held in the customer’s accounts. A broker would be required to provide the bid and offer quotations and compensation information before effecting the transaction. This information must be contained in the customer’s confirmation. Generally, brokers are less willing to effect transactions in penny stocks due to these additional delivery requirements. These requirements may make it more difficult for shareholders to purchase or sell the shares of our common stock. Since the broker, not us, prepares this information, we would not be able to assure that such information is accurate, complete or current.
Some provisions of Florida law and our amended and restated articles of incorporation and amended and restated bylaws may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our shareholders and may prevent attempts by our shareholders to replace or remove our current management.
Our status as a Florida corporation and the anti-takeover provisions of the Florida Business Corporation Act, which we sometimes refer to as the FBCA, may discourage, delay or prevent a change in control even if a change in control would be beneficial to our shareholders.
The control share acquisition statute, Section 607.0902 of the FBCA, generally provides that in the event a person acquires voting shares of the company in excess of 20% of the voting power of all of our issued and outstanding shares, such acquired shares will not have any voting rights unless such rights are restored by the holders of a majority of the votes of each class or series entitled to vote separately, excluding shares held by the person acquiring the control shares or any of our officers or employees who are also directors of the company. Certain acquisitions of shares are exempt from these rules, such as shares acquired pursuant to the laws of intestate succession or pursuant to a gift or testamentary transfer, pursuant to a merger or share exchange effected in compliance with the FBCA if we are a party to the agreement, or pursuant to an acquisition of our shares if the acquisition has been approved by our board of directors before the acquisition. The control share acquisition statute generally applies to any “issuing public corporation,” which means a Florida corporation which has:
| ● | One hundred or more shareholders; |
| ● | Its principal place of business, its principal office, or substantial assets within Florida; and |
| ● | Either (i) more than 10% of its shareholders are resident in Florida; (ii) more than 10% of its shares are owned by residents of Florida; or (iii) one thousand shareholders are resident in Florida. |
The affiliated transaction (or so-called “business combination”) statute, Section 607.0901 of the FBCA, provides that we may not engage in certain mergers, consolidations, sales of assets, issuances of stock, reclassifications, recapitalizations, and other affiliated transactions with any “interested shareholder” for a period of three years following the time that such shareholder became an interested shareholder, unless:
| ● | Prior to the time that such shareholder became an interested shareholder, our board of directors approved either the affiliated transaction or the transaction which resulted in the shareholder becoming an interested shareholder; or; |
| ● | Upon consummation of the transaction that resulted in the shareholder becoming an interested shareholder, the interested shareholder owned at least 85% of our voting shares outstanding at the time the transaction commenced; or |
| ● | At or subsequent to the time that such shareholder became an interested shareholder, the affiliated transaction is approved by our board of directors and authorized at an annual or special meeting of shareholders, and not by written consent, by the affirmative vote of at least two-thirds of the outstanding voting shares which are not owned by the interested shareholder. |
An “interested shareholder” is generally defined as any person who is the beneficial owner of more than 15% of our outstanding voting shares. Currently, Bay Shore Trust would be considered an “interested shareholder.”
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The voting requirements set forth above do not apply to a particular affiliated transaction if one or more conditions are met, including, but not limited to, the following: if the affiliated transaction has been approved by a majority of our disinterested directors; if we have not had more than 300 shareholders of record at any time during the three years preceding the date the affiliated transaction is announced; if the interested shareholder has been the beneficial owner of at least 80% of our outstanding voting shares for at least three years preceding the date the affiliated transaction is announced; or if the consideration to be paid to the holders of each class or series of voting shares in the affiliated transaction meets certain requirements of the statute with respect to form and amount, among other things.
Both the control share acquisition statute and the affiliated transactions statute may have the effect of discouraging or preventing certain change of control or takeover transactions involving us.
In addition, our amended and restated articles of incorporation and amended and restated bylaws contain provisions that may make it more difficult for a third party to acquire us or increase the cost of acquiring us, even if doing so would benefit our shareholders, including transactions in which shareholders might otherwise receive a premium for their shares. These provisions include:
| ● | nothing in our amended and restated articles of incorporation precludes future issuances without shareholder approval of the authorized but unissued shares of our common stock; | |
| ● | advance notice procedures apply for shareholders to nominate candidates for election as directors or to bring matters before an annual meeting of shareholders; | |
| ● | a special meeting of shareholders can only be called by our chairman of the board of directors, our chief executive officer, our president (in the absence of a chief executive officer), a majority of our board of directors or the holders of 10% or more of all of our votes entitled to be cast on any issue proposed to be considered at the special meeting of shareholders; | |
| ● | no provision in our amended and restated articles of incorporation or amended and restated bylaws provides for cumulative voting, which limits the ability of minority shareholders to elect director candidates; | |
| ● | directors will only be able to be removed for cause; | |
| ● | our amended and restated articles of incorporation authorizes undesignated preferred stock, the terms of which may be established and shares of which may be issued, without the approval of the holders of our capital stock; and | |
| ● | certain litigation against us can only be brought in Florida. |
These provisions could discourage, delay or prevent a transaction involving a change in control of our company. These provisions could also discourage proxy contests and make it more difficult for you and other shareholders to elect directors of your choosing and cause us to take corporate actions other than those you desire. See “Description of Capital Stock.”
Our amended and restated bylaws designates the state courts located within the state of Florida as the exclusive forum for substantially all disputes between us and our shareholders and the federal district courts as the exclusive forum for Securities Act claims, which could limit our shareholders’ ability to obtain a favorable judicial forum for disputes with us.
Our amended and restated bylaws provide that, unless we consent in writing to the selection of an alternative forum, the sole and exclusive forum for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of breach of a fiduciary duty owed by any of our current or former directors, officers or other employees to us or our shareholders, (iii) any action arising pursuant to any provision of the FBCA, our amended and restated articles of incorporation or our amended and restated bylaws, or (iv) any other action asserting a claim that is governed by the internal affairs doctrine shall be a state court located within the state of Florida (or, if a state court located within the state of Florida does not have jurisdiction, the federal district court for the Middle District of Florida); provided that, the exclusive forum provision will not apply to suits brought to enforce any liability or duty created by the Exchange Act, or to any claim for which the federal courts have exclusive jurisdiction. Our amended and restated bylaws also provide that, unless we consent in writing to the selection of an alternative forum, the U.S. federal district courts shall be the exclusive forum for the resolution of any claims arising under the Securities Act. Under the Securities Act, federal and state courts have concurrent jurisdiction over all suits brought to enforce any duty or liability created by the Securities Act, and investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Accordingly, there is uncertainty as to whether a court would enforce such a forum selection provision as written in connection with claims arising under the Securities Act.
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By becoming a shareholder in our company, you will be deemed to have notice of and have consented to the provisions of our amended and restated bylaws related to choice of forum. The choice of forum provisions in our amended and restated bylaws may limit our shareholders’ ability to obtain a favorable judicial forum for disputes with us. Additionally, the enforceability of choice of forum provisions in other companies’ governing documents has been challenged in legal proceedings, and it is possible that, in connection with any applicable action brought against us, a court could find the choice of forum provisions contained in our amended and restated bylaws to be inapplicable or unenforceable in such action. If so, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, results of operations, and financial condition.
Securities or industry analysts may not regularly publish reports on us, which could cause the price of our securities or trading volumes to decline.
The trading market for our securities could be influenced by research and reports that industry and/or securities analysts may publish us, our business, the market or our competitors. We do not have any control over these analysts and cannot be assured that such analysts will cover us or provide favorable coverage. If any of the analysts who may cover our business change their recommendation regarding our securities adversely, or provide more favorable relative recommendations about our competitors, the price of our securities would likely decline. If any analysts who may cover our business were to cease coverage or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause the price of our securities or trading volumes to decline.
We will likely conduct further offerings of our equity securities in the future, in which case your proportionate interest may become diluted.
We will likely be required to conduct equity offerings in the future to finance our current projects or to finance subsequent projects that we decide to undertake. If our common stock shares are issued in return for additional funds, the price per share could be lower than that paid by our current shareholders. We anticipate continuing to rely on equity sales of our common stock shares in order to fund our business operations. If we issue additional common stock shares or securities convertible into shares of our common stock, your percentage interest in us could become diluted.
We may issue shares of preferred stock in the future, which could make it difficult for another company to acquire us or could otherwise adversely affect holders of our common stock, which could depress the price of our common stock.
Our certificate of incorporation authorizes us to issue one or more series of preferred stock. Our board of directors will have the authority to determine the preferences, limitations and relative rights of the shares of preferred stock and to fix the number of shares constituting any series and the designation of such series, without any further vote or action by our shareholders. Our preferred stock could be issued with voting, liquidation, dividend and other rights superior to the rights of our common stock. The potential issuance of preferred stock may delay or prevent a change in control of us, discouraging bids for our common stock at a premium to the market price, and materially adversely affect the market price and the voting and other rights of the holders of our common stock.
We have never declared or paid any cash dividends or distributions on our capital stock. We do not anticipate paying any cash dividends on our common stock in the foreseeable future.
We have never declared or paid any cash dividends or distributions on our capital stock. We currently intend to retain our future earnings, if any, to support operations and to finance expansion and therefore we do not anticipate paying any cash dividends on our common stock in the foreseeable future.
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The declaration, payment and amount of any future dividends will be made at the discretion of the board of directors, and will depend upon, among other things, the results of our operations, cash flows and financial condition, operating and capital requirements, and other factors as the board of directors considers relevant. There is no assurance that future dividends will be paid, and, if dividends are paid, there is no assurance with respect to the amount of any such dividend.
Item 1B. Unresolved Staff Comments.
None.
Item 1C. Cybersecurity.
We
recognize the importance of
Identifying and assessing cybersecurity risk is integrated into our overall risk management systems and processes. Cybersecurity risks related to our business, technical operations, privacy and compliance issues are identified and addressed through a multi-faceted approach including third party assessments, internal IT Audit, IT security, governance, risk and compliance reviews. To defend, detect and respond to cybersecurity incidents, we, among other things: conduct proactive privacy and cybersecurity reviews of systems and applications, audit applicable data policies, conduct employee training, monitor emerging laws and regulations related to data protection and information security and implement appropriate changes.
Our
risk management program also assesses third party risks, and we perform third-party risk management to identify and mitigate risks from
third parties such as vendors, suppliers, and other business partners associated with our use of third-party service providers. Cybersecurity
risks are evaluated when determining the selection and oversight of applicable
To
date,
To manage our cybersecurity governance, we use Coalition Control, a cyber risk management platform that combines insurance, technology, and services from Coalition and its partners into an online experience. It allows us to detect, assess, and mitigate cyber risks proactively. Coalition Control monitors and detects risks across our entire external digital footprint, including assets, apps, services, and data leaks. The tool shows us where any potential vulnerabilities are identified and how to fix them.
Item 2. Description of Property.
Our current business address is 1200 Brickell Avenue, Suite 1950 #1183, Miami, Florida 33131, which is a virtual office.
Item 3. Legal Proceedings.
None
Item 4. Mine Safety Disclosures
Not applicable.
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PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Market Information
Our common stock has been public traded on The Nasdaq Capital Market under the symbol “MIRA” since August 3, 2023. Prior to that date, there was no public trading market for our common stock.
Holders of Common Stock
As of March 31, 2026, we had approximately 69 holders of record of our common stock. No cash dividends have been paid on the common stock to date. We currently intend to retain earnings for further business development and do not expect to pay cash dividends in the foreseeable future.
Securities Authorized for Issuance Under Equity Compensation Plans
See Item 12 - Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
Unregistered Sales of Equity Securities and Use of Proceeds
None
Issuer Purchases of Equity Securities
None
Item 6. Reserved
Item 7.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis provide information which our management believes is relevant to an assessment and understanding of our results of operations and financial condition. You should read the following discussion and analysis of our results of operations and financial condition together with our financial statements and related notes and other information included elsewhere in this Report.
In addition to historical financial information, this discussion contains forward-looking statements based upon our current expectations that involve risks and uncertainties. Our actual results could differ materially from such forward-looking statements as a result of various factors, including those set forth under “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” included elsewhere in this Report. Additionally, our historical results are not necessarily indicative of the results that may be expected for any period in the future.
Overview
MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA) is a clinical-stage pharmaceutical development company advancing two neuroscience programs targeting neurologic and neuropsychiatric disorders. The company holds exclusive rights in the U.S., Canada, and Mexico for Ketamir-2 and MIRA-55, two novel drug candidates designed to address unmet medical needs in pain management, depression, PTSD and cognitive function.
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Ketamir-2 is a next-generation oral NMDA-receptor antagonist currently being evaluated in an ongoing Phase 1 clinical trial in healthy volunteers. The single-ascending-dose (SAD) portion of the study has been completed, and data remain blinded pending full analysis. The multiple-ascending-dose (MAD) portion is underway, and a Phase 2a study in chemotherapy-induced peripheral neuropathy (CIPN) is planned to begin in the first half of 2026, subject to regulatory feedback and site readiness.
MIRA-55 is a novel oral, non-psychoactive pharmaceutical-marijuana analog under preclinical investigation for anxiety, cognitive decline, and inflammatory pain. Recent animal studies demonstrated that MIRA-55 produced analgesic and anti-inflammatory effects in validated preclinical pain models without evidence of local irritation or psychoactive side effects. These findings support continued advancement toward IND-enabling studies.
The U.S. Drug Enforcement Administration (DEA) has completed its scientific review of both Ketamir-2 and MIRA-55 and concluded that neither compound would be considered a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations.
On September 29, 2025, MIRA acquired SKNY Pharmaceuticals (“SKNY”), a related party private company developing SKNY-1, a preclinical-stage oral therapeutic designed to modulate CB1, CB2, and MAO-B pathways to influence energy balance, lipid metabolism, appetite, cravings, and reward—without the psychiatric side effects that limited earlier CB1-targeting drugs.
SKNY-1 has been evaluated in preclinical behavioral and metabolic models. SKNY-1 administration was associated with reductions in food consumption, body-weight gain, and nicotine-seeking behavior compared with controls. These findings support continued preclinical development of SKNY-1 in models of metabolic and behavioral modulation.
We had net losses of $10.4 million and $7.9 million for the years ended December 31, 2025 and 2024, respectively.
Components of our Results of Operations
Research and Development Expenses
Research and development expenses represent costs incurred to conduct research and development of our product candidate. We recognize all research and development costs as they are incurred. Research and development expenses consist primarily of the following:
| ● | contracted research and manufacturing; |
| ● | patent-related costs; |
| ● | consulting arrangements; and |
| ● | other expenses incurred to advance our research and development activities. |
Our operating expenses have historically been the costs associated with our patent prosecution and initial investment in pre-clinical research and development activities. We expect research and development expenses will increase in the future as we advance Ketamir-2 and MIRA-55 into and through clinical trials and pursue regulatory approvals, which will require a significant investment in costs of clinical trials, regulatory support, and contract manufacturing. In addition, we will evaluate opportunities to acquire or in-license additional product candidates and technologies, which may result in higher research and development expenses due to license fee and/or milestone payments, as well as added clinical development costs.
The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in timely development and achieving regulatory approval for our product candidates. The probability of success of our product candidates may be affected by numerous factors, including clinical data, competition, manufacturing capability and commercial viability. As a result, we are unable to determine the duration and completion costs of our development projects or when and to what extent we will generate revenue from the commercialization and sale of our product candidates.
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General and Administrative Expenses
General and administrative expenses consist of employee-related expenses, including salaries, benefits, and travel, and other administrative functions, as well as fees paid for legal, accounting, and tax services, consulting fees, and facilities costs not otherwise included in research and development expense. Legal costs include general corporate legal fees. As a result of becoming a public company, we now incur additional expenses related to compliance with the rules and regulations of the SEC and Nasdaq, as well as additional costs for insurance, investor relations, professional accounting and legal services, and other administrative expenses.
Other Income, net
Other income, net consists of interest income earned from investment of excess operating cash, less interest expense, and the unrealized loss on short-term investments.
Results of Operations for the years ended December 31, 2025 and 2026 are as follows:
| Year Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenues | $ | — | $ | — | ||||
| Operating costs: | ||||||||
| General and administrative expenses | 8,773,329 | 4,712,753 | ||||||
| Research and development expenses | 1,719,783 | 3,305,575 | ||||||
| Total operating costs | 10,493,112 | 8,018,328 | ||||||
| Other income (expense): | ||||||||
| Interest income | 98,911 | 165,669 | ||||||
| Other expense | (13,072 | ) | — | |||||
| Unrealized loss on short-term investment | (35,212 | ) | — | |||||
| Total other income, net | 50,627 | 165,669 | ||||||
| Net Loss | (10,442,485 | ) | (7,852,659 | ) | ||||
| Deemed dividend | (21,556,821 | ) | — | |||||
| Net loss attributable to common stockholders | $ | (31,999,306 | ) | $ | (7,852,659 | ) | ||
| Basic and diluted loss per share | $ | (1.35 | ) | $ | (0.51 | ) | ||
| Basic weighted average common stock shares outstanding | 23,694,333 | 15,444,149 | ||||||
General and Administrative Expenses. We incurred $8.8 million and $4.7 million in general and administrative expenses during the years ended December 31, 2025 and 2024, respectively. General and administrative expenses in 2025 consisted of stock compensation expense of $6.3 million, payroll expense of $1.3 million, accounting and legal expenses of $0.3 million, marketing, investor relations, advertising, and general corporate expenses of $0.5 million and insurance expenses of $0.4 million. The increase in general and administrative expenses during 2025 relate primarily to increase in stock-based compensation and payroll related expenses.
Interest income (expense). We earned $0.1 million in interest income during the year ended December 31, 2025, which consisted of income earned from funds in a money market account, as compared to less than $0.2 million earned during the year ended December 31, 2024.
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Research and Development Expenses. During the year ended December 31, 2025, we incurred $1.7 million in research and development expenses, which were primarily related to pre-IND submission work and consultants. During the year ended December 31, 2024, we incurred $3.3 million in research and development expenses primarily related to initial payments for toxicology studies, consultants and stock compensation. The decrease in research and development expenses during 2025 is due to decreased development costs for MIRA-55. Major components of research and development expenses during the year ended December 31, 2025 are as follows:
| R&D Category | Expense | |||
| R&D consultants | $ | 0.37 million | ||
| R&D research | $ | 1.17 million | ||
| R&D toxicology | $ | 0.13 million | ||
| R&D stock compensation | $ | 0.05 million |
Liquidity and Capital Resources
Since our inception in September 2020, we have financed our operations primarily through an unsecured line of credit with a major shareholder and an affiliated company and through a private placement of shares of our common stock that occurred during the fourth quarter 2021 and during 2022 and our IPO that occurred in August 2023. We intend to finance our clinical development programs and working capital needs from existing cash, potential new sources of debt and equity financing, and through proceeds of an ATM offering. In the years ended December 31, 2025 and 2024 we raised $6.7 million and $3.6 million, respectively, in ATM financings. We may also enter into new licensing and commercial partnership agreements.
On August 12, 2024, the Company filed a shelf registration statement on Form S-3 with the SEC. The terms of any offering under the shelf registration statement will be established at the time of such offering and will be described in a prospectus supplement filed with the SEC prior to completion of any such offering.
We used $4.7 million in operating activities during the year ended December 31, 2025, compared to $5.6 million in operating activities during the year ended December 31, 2024.
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We have incurred significant losses and negative cash flows from operations since inception and expect to incur additional losses until such time that we can generate significant revenue and profit. We had negative cash flow from operations of approximately $4.7 million for the year ended December 31, 2025, and an accumulated deficit of approximately $39.6 million as of December 31, 2025. As of December 31, 2025, we had cash and cash equivalents of approximately $6.3 million. We currently expect that our cash and cash equivalents be sufficient to fund our operations, development plans, and capital expenditures into at least the first quarter of 2027.
We did not have any material non-cancellable contractual obligations as of December 31, 2025.
Cash Flows
The following table provides information regarding our cash flows for the periods presented:
| Year ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Net cash provided by (used in): | ||||||||
| Operating activities | $ | (4,661,669 | ) | $ | (5,560,606 | ) | ||
| Financing activities | 8,175,659 | 3,790,971 | ||||||
| Net change in cash | $ | 3,513,930 | $ | (1,769,635 | ) | |||
Net Cash Used in Operating Activities
For the year ended December 31, 2025, the cash used in operating activities of $4.7 million resulted from net losses of $10.4 million, offset by $6.3 million stock-based compensation expense and $0.6 and million change in accounts payable, and prepaid expenses.
For the year ended December 31, 2024, cash used in operating activities of $5.6 million resulted from a net loss of $7.9 million, offset by $1.9 million in stock-based compensation expense, and a $0.4 million change in accounts payable, accrued liabilities, and prepaid expenses. Accounts payable, accrued liabilities, and prepaid expenses were primarily composed of research and development payables, consultant costs, insurance costs and investor relations expenses.
Net Cash Provided by Financing Activities
During the year ended December 31, 2025, the Company raised approximately $8.2 million from financing activities, comprised of $7.0 million from sales of common stock, reduced by $0.3 million in offering costs, $0.9 million in proceeds from stock option exercises, and $0.6 million in proceeds from related party.
During the year ended December 31, 2024, the Company raise approximately $3.8 million from financing activities, including $3.6 million in proceeds from sale of common stock, net of offering costs, and $0.1 million from the Bay Shore Trust short-swing disgorgement.
We currently anticipate that we will seek to monetize our product candidates, Ketamir-2, MIRA-55, and SKNY-1, at the end of our planned Phase II studies. Prior to that time, we anticipate that additional capital may be required to support ongoing activities and further phases of development. Should that be required, our available capital may be consumed more rapidly than currently anticipated, resulting in the need for additional funding. In addition, there can be no assurance that additional funding, when and if required, will be available at commercially favorable terms, if at all.
| 59 |
Accordingly, we may need to raise additional capital, which may be available to us through a variety of sources, including:
| ● | public equity markets; |
| ● | private equity financings; |
| ● | commercialization agreements and collaborative arrangements; |
| ● | sale of product royalty; |
| ● | grants and new license revenues; |
| ● | bank loans; and |
| ● | public or private debt. |
Additional funding, capital, or loans (including, without limitation, milestone, or other payments from potential commercialization agreements) may be unavailable on favorable terms, if at all. If adequate funds are not available, we may be required to significantly reduce or refocus our operations or to obtain funds through arrangements that may require us to relinquish rights to certain technologies and drug formulations or potential markets, any of which could have a material adverse effect on us, our financial condition, and our results of operations. To the extent that additional capital is raised through the sale of equity or convertible debt securities or exercise of warrants and options, the issuance of such securities would result in ownership dilution to existing stockholders.
If we are unable to attract additional funds on commercially acceptable terms, it may adversely affect our ability to achieve our development and commercialization goals, which could have a material and adverse effect on our business, results of operations and financial condition.
We believe that we have sufficient resources available to support our development activities and business operations and timely satisfy our obligations as they become due into the third quarter of 2025. We do not have sufficient cash and cash equivalents as of the date of filing this Annual Report on Form 10-K to support our operations for at least the 12 months following the date the financial statements are issued. These conditions raise substantial doubt about our ability to continue as a going concern through 12 months after the date that the financial statements are issued.
To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, we plan to secure additional capital, potentially through a combination of public or private equity offerings and strategic transactions, including potential alliances and drug product collaborations; however, none of these alternatives are committed at this time. There can be no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all, identify and enter into any strategic transactions that will provide the capital that we will require or achieve the other strategies to alleviate the conditions that raise substantial doubt about our ability to continue as a going concern. If none of these alternatives are available, or if available, are not available on satisfactory terms, we will not have sufficient cash resources and liquidity to fund our business operations for at least the 12 months following the date the financial statements are issued. The failure to obtain sufficient capital on acceptable terms when needed may require us to delay, limit, or eliminate the development of business opportunities and our ability to achieve our business objectives and our competitiveness, and our business, financial condition, and results of operations will be materially adversely affected. In addition, the perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns about our ability to meet our contractual obligations.
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.
| 60 |
Recently Issued and Adopted Accounting Pronouncements
A description of recently issued and adopted accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 1 to our financial statements appearing at the end of this Report.
Off-Balance Sheet Arrangements
During the periods presented, we did not have, nor do we currently have, any off-balance sheet arrangements as defined under SEC rules.
Summary of Critical Accounting Policies and Estimates
Research and development expenses
Research and development costs are expensed in the period in which they are incurred and include the expenses paid to third parties, such as contract research organizations and consultants, who conduct research and development activities on our behalf. Patent-related costs, including registration costs, documentation costs and other legal fees associated with the application, are expensed in the period in which they are incurred.
Investments in Equity Securities, at Fair Value
Equity investments are carried at fair value with unrealized gains or losses recorded as net unrealized gain (loss) on equity investments, a component of other income, in the accompanying consolidated statements of operations. Realized gains and losses are determined on a specific identification basis which is recorded in earnings or loss as a net realized gain (loss) on equity investments in the consolidated statement of operations. The Company reviews investments in equity securities, at fair value, for impairment whenever circumstances and situations change such that there is an indication that the carrying amounts may not be recovered.
Stock-based compensation
We account for stock-based compensation under the provisions of FASB ASC 718, “Compensation - Stock Compensation”, which requires the measurement and recognition of compensation expense for all stock-based awards made to employees, directors and consultants based on estimated fair values on the grant date. We estimate the fair value of stock-based awards on the date of grant using the Black-Scholes model. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods using the straight-line method. We have elected to account for forfeiture of stock-based awards as they occur.
Emerging Growth Company Election
We are an “emerging growth company” as defined in Section 2(a) of the Securities Act and have elected to take advantage of the benefits of the extended transition period for new or revised financial accounting standards. We expect to continue to take advantage of the benefits of the extended transition period, although we may decide to early adopt such new or revised accounting standards to the extent permitted by such standards. We expect to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and non-public companies until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. This may make it difficult or impossible to compare our financial results with the financial results of another public company that is either not an emerging growth company or is an emerging growth company that has chosen not to take advantage of the extended transition period exemptions because of the potential differences in accounting standards used.
In addition, we intend to rely on the other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act and compliance with applicable laws, if, as an emerging growth company, we rely on such exemptions, we are not required to, among other things: (a) provide an auditor’s attestation report on our system of internal control over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002; (b) provide all of the compensation disclosures that may be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010; (c) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis); and (d) disclose certain executive compensation-related items such as the correlation between executive compensation and performance and comparisons of the Chief Executive Officer’s compensation to median employee compensation.
We will remain an emerging growth company under the JOBS Act until the earliest of (a) December 31, 2028, (b) the last date of our fiscal year in which we had total annual gross revenue of at least $1.07 billion, (c) the date on which we are deemed to be a “large accelerated filer” under the rules of the SEC or (d) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the previous three years.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Smaller reporting companies are not required to provide the information required by this item.
| 61 |
Item 8. Financial Statements and Supplementary Data
MIRA PHARMACEUTICALS, INC.
INDEX TO FINANCIAL STATEMENTS
| F-1 |
Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of:
MIRA Pharmaceuticals, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of MIRA Pharmaceuticals, Inc. (the “Company”) as of December 31, 2025 and 2024, the related consolidated statements of operations, changes in stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the consolidated financial position of the Company as of December 31, 2025 and 2024, and the consolidated results of its operations and its cash flows for each of the two years in the period ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America.
Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the consolidated financial statements, the Company used approximately $4.6 million of cash in operations and had a net loss of $10.4 million during the year ended December 31, 2025. These matters raise substantial doubt about the Company’s ability to continue as a going concern. Management’s Plans in regard to these matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Salberg & Company, P.A.
We have served as the Company’s auditor since 2024.
March 31, 2026
2295 NW Corporate Blvd., Suite 240 ● Boca Raton, FL 33431-7326
Phone: (561) 995-8270 ● Toll Free: (866) CPA-8500 ● Fax: (561) 995-1920
www.salbergco.com ● [email protected]
Member National Association of Certified Valuation Analysts ● Registered with the PCAOB
Member CPAConnect with Affiliated Offices Worldwide ● Member AICPA Center for Audit Quality
| F-2 |
MIRA PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
| December 31, | ||||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash | $ | $ | ||||||
| Prepaid expenses | ||||||||
| Short-term investment, at fair value – related party | ||||||||
| Total current assets | ||||||||
| Related party receivable | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Trade accounts payable and accrued liabilities | $ | $ | ||||||
| Due to related party | ||||||||
| Total current liabilities | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (Note 7) | ||||||||
| Stockholders’ Equity | ||||||||
| Preferred Stock, $ par value, shares authorized and issued or outstanding. | ||||||||
| Common Stock, $ par value; shares authorized, and shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively. | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
The accompanying notes are an integral part of these consolidated financial statements.
| F-3 |
MIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
| Year Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenues | $ | $ | ||||||
| Operating costs: | ||||||||
| General and administrative expenses | ||||||||
| Research and development expenses | ||||||||
| Total operating costs | ||||||||
| Other income (expense): | ||||||||
| Interest income | ||||||||
| Other expense | ( | ) | ||||||
| Unrealized loss on short-term investment | ( | ) | ||||||
| Total other income, net | ||||||||
| Net Loss | ( | ) | ( | ) | ||||
| Deemed dividend | ( | ) | ||||||
| Net loss attributable to common stockholders | $ | ( | ) | $ | ( | ) | ||
| Basic and diluted loss per share | $ | ) | $ | ) | ||||
| Basic weighted average common stock shares outstanding | ||||||||
The accompanying notes are an integral part of these consolidated financial statements.
| F-4 |
MIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
| Common Stock | Additional Paid-In | Accumulated | Total Stockholders’ Equity | |||||||||||||||||
| Shares | Amount | Capital | Deficit | (Deficit) | ||||||||||||||||
| Balances, December 31, 2023 | $ | $ | $ | ( | ) | $ | | |||||||||||||
| Issuance of common stock-ATM, net of $ | ||||||||||||||||||||
| Payment of short swing disgorgement by Bay Shore Trust | — | |||||||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||
| Net loss | — | ( | ) | ( | ) | |||||||||||||||
| Balances, December 31, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Issuance of common stock-ATM, net of $ | ||||||||||||||||||||
| Issuance of common stock, SKNY acquisition | ||||||||||||||||||||
| Common stock issued for option exercises | ||||||||||||||||||||
| Common stock issued for vested RSU | ( | ) | ||||||||||||||||||
| Common stock granted to officer | ||||||||||||||||||||
| Stock -based compensation | — | |||||||||||||||||||
| Stock -based compensation – stock option modification | — | |||||||||||||||||||
| Net loss | — | ( | ) | ( | ) | |||||||||||||||
| Balances, December 31, 2025 | $ | $ | $ | ( | ) | $ | ||||||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
| F-5 |
MIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
| Year Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operations | ||||||||
| Stock-based compensation expense | ||||||||
| Unrealized loss on short-term investments | ||||||||
| Change in operating assets and liabilities: | ||||||||
| Prepaid expenses | ||||||||
| Other receivables | ||||||||
| Trade accounts payable and accrued expenses | ( | ) | ||||||
| Related party accrued interest | ( | ) | ||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Financing activities: | ||||||||
| Offering costs | ( | ) | ||||||
| Proceeds from related party | ||||||||
Proceeds from Common stock option exercises | ||||||||
| Advances from (to) affiliates | ||||||||
| Bayshore Trust short-swing disgorgement | ||||||||
| Proceeds from sale of common stock | ||||||||
| Net cash provided by financing activities | ||||||||
| Net increase (decrease) in cash | ( | ) | ||||||
| Cash, beginning of year | ||||||||
| Cash, end of year | $ | $ | ||||||
| Supplemental disclosure of cash flow information | ||||||||
| Cash paid for interest | $ | $ | ||||||
| Cash paid for income taxes | $ | $ | ||||||
| Supplemental schedule of non-cash financing activities: | ||||||||
| Deferred offering costs charged to additional paid-in capital | $ | $ | ||||||
| Issuance of common stock for the short-term investments, SKNY acquisition | $ | $ | ||||||
The accompanying notes are an integral part of these consolidated financial statements.
| F-6 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2025 AND 2024
Note 1. Description of business and summary of significant accounting policies:
Overview
MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) is a clinical-stage pharmaceutical development company focused on developing novel oral small-molecule therapeutics for neurologic, neuropsychiatric, metabolic, and inflammatory disorders. The Company’s pipeline includes three product candidates: Ketamir-2, MIRA-55, and SKNY-1.
Ketamir-2 is a next-generation oral NMDA receptor modulator that has completed Phase 1 clinical development and is being advanced toward Phase 2a clinical studies for neuropathic pain. MIRA-55 is a novel oral cannabinoid analog in preclinical development for inflammatory pain and related conditions. SKNY-1 is a preclinical-stage oral therapeutic designed to modulate CB1, CB2, and monoamine oxidase B (MAO-B) pathways and is being developed for obesity and nicotine dependence.
On June 13, 2025, the Company formed MIRAPHARM Acquisition, Inc., a wholly owned Delaware subsidiary, to support the acquisition of SKNY Pharmaceuticals, Inc., a private company developing SKNY-1 (See Note 5, Asset Acquisition) and related party due to common shareholders and a shared licensor. On September 29, 2025, the Company completed a stock-for-stock merger, with SKNY surviving as the Company’s wholly owned subsidiary.
As used herein, the Company’s Common Stock, par value $ per share, is referred to as the “Common Stock” and the Company’s preferred stock, par value $ per share, is referred to as the “Preferred Stock”.
Basis of Presentation and Principles of Consolidation
The Company’s financial statements have been prepared in accordance with generally accepted accounting principles in the United States of American (GAAP) as determined by the Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC). The consolidated financial statements include the accounts of MIRA Pharmaceuticals, Inc. and its wholly owned subsidiary. All intercompany transactions and balances have been eliminated in consolidation.
Use of estimates
The preparation of these consolidated financial statements in accordance with GAAP requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses, and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements. Actual results may differ from such estimates and such differences could be material. Significant estimates during the reporting periods include the value of equity investments held, value of common shares issued in an acquisition, stock-based compensation and the deferred tax asset valuation allowance.
Certain Risks and Uncertainties
The Company’s activities are subject to significant risks and uncertainties, including the risk of failure to secure additional funding to properly execute the Company’s business plan. The Company is subject to risks that are common to companies in the pharmaceutical industry, including, but not limited to, development by the Company or its competitors of new technological innovations, dependence on key personnel, reliance on third party manufacturers, protection of proprietary technology, and compliance with regulatory requirements.
| F-7 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2025 AND 2024
Cash
The
Company considers all highly liquid debt instruments and other short-term investments with maturities of three months or less, when purchased,
to be cash equivalents. The Company maintains cash and cash equivalent balances at two financial institutions that are insured by the
Federal Deposit Insurance Corporation (“FDIC”). The Company’s account at these institutions are insured by the FDIC
up to $
Investments in Equity Securities, at Fair Value
Equity investments are carried at fair value with unrealized gains or losses recorded as net unrealized gain (loss) on equity investments, a component of other income, in the accompanying consolidated statements of operations. Realized gains and losses are determined on a specific identification basis which is recorded in earnings or loss as a net realized gain (loss) on equity investments in the consolidated statement of operations. The Company reviews investments in equity securities, at fair value, for impairment whenever circumstances and situations change such that there is an indication that the carrying amounts may not be recovered.
Fair Value of Financial Instruments
The Company measures the fair value of financial instruments in accordance with GAAP, which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements.
GAAP defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. GAAP also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The Company considers the carrying amount of deferred offering costs to approximate fair value due to short-term nature of this instrument. GAAP describes three levels of inputs that may be used to measure fair value:
Level 1 - quoted prices in active markets for identical assets or liabilities.
Level 2 - quoted prices for similar assets and liabilities in active markets or inputs that are observable.
Level 3 - inputs that are unobservable (for example cash flow modeling inputs based on assumptions).
| December 31, 2025 | Level 1 | Level 2 | Level 3 | |||||||||||||
| Assets | ||||||||||||||||
| Short-term investments | $ | $ | $ | $ | ||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
| December 31, 2024 | Level 1 | Level 2 | Level 3 | |||||||||||||
| Assets | ||||||||||||||||
| Short-term investments | $ | $ | $ | $ | ||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
Revenue Recognition
The Company has not generated revenue from contracts with customers as of December 31, 2025. The Company will recognize revenue in accordance with ASC 606, Revenue from Contracts with Customers, when it satisfies its performance obligations by transferring control of promised goods or services to customers, in an amount that reflects the consideration to which the Company expects to be entitled.
Research and Development Expenses
Research and development costs are expensed in the period in which they are incurred and include the expenses paid to third parties, such as contract research organizations and consultants, who conduct research and development activities on behalf of the Company. Patent-related costs, including registration costs, documentation costs and other legal fees associated with the application, are expensed in the period in which they are incurred.
General and Administrative Expenses
General and administrative expenses are primarily comprised of personnel costs, insurance expenses, professional services fees, travel and office expenses, and stock-based compensation. General and administrative expenses are expensed as incurred.
| F-8 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2025 AND 2024
Stock-Based Compensation
The Company accounts for stock-based compensation under the provisions of FASB ASC 718, “Compensation - Stock Compensation.” Stock-based compensation cost for equity-classified awards is measured at the grant-date fair value of the award and is recognized as expense over the requisite service period, generally on a straight-line basis. The Company estimates the fair value of stock-based awards on the date of grant using the Black-Scholes option pricing model, which requires the use of subjective assumptions including expected volatility, expected term, risk-free interest rate, and expected dividends. The Company has elected to account for forfeiture of stock-based awards as they occur.
Income Taxes
The Company accounts for income taxes pursuant to the provision of Accounting Standards Codification (“ASC”) 740-10, “Accounting for Income Taxes” (“ASC 740-10”), which requires, among other things, an asset and liability approach to calculating deferred income taxes. The asset and liability approach requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amounts and the tax bases of assets and liabilities. A valuation allowance is provided to offset any net deferred tax assets for which management believes it is more likely than not that the net deferred asset will not be realized.
The Company follows the provision of ASC 740-10 related to Accounting for Uncertain Income Tax Positions. When tax returns are filed, there may be uncertainty about the merits of positions taken or the amount of the position that would be ultimately sustained. In accordance with the guidance of ASC 740-10, the benefit of a tax position is recognized in the consolidated financial statements in the period during which, based on all available evidence, management believes it is more likely than not that the position will be sustained upon examination, including the resolution of appeals or litigation processes, if any. Tax positions taken are not offset or aggregated with other positions. Tax positions that meet the more likely than not recognition threshold are measured at the largest amount of tax benefit that is more than 50 percent likely of being realized upon settlement with the applicable taxing authority. The portion of the benefit associated with tax positions taken that exceed the amount measured as described above should be reflected as a liability for uncertain tax benefits in the accompanying balance sheet along with any associated interest and penalties that would be payable to the taxing authorities upon examination. The Company believes its tax positions are all more likely than not to be upheld upon examination. As such, the Company has not recorded a liability for uncertain tax benefits.
Operating Segments
The Company’s Chief Operating Decision Maker (CODM) is its Chief Executive Officer, who reviews financial information presented for purposes of making operating decisions, assessing financial performance, and allocating resources. The Company operates as a single operating and reportable segment, consistent with the manner in which the CODM evaluates performance and allocates resources, see Note 10 for further information.
Leases
The Company has accounted for leases under the provisions of FASB ASC Topic 842, “Leases”, which requires the Company to recognize right-to-use (ROU) assets and lease liabilities for operating leases on the balance sheet.
Contingencies
In the normal course of business, the Company may be subject to loss contingencies, such as legal proceedings, amounts arising from contractual arrangements and claims arising out of the Company’s business that cover a wide range of matters, including, among others, government investigations, shareholder lawsuits, and tax matters. In accordance with ASC Topic 450, Accounting for Contingencies, (ASC 450), the Company records accruals for such loss contingencies when it is probable that a liability will be incurred, and the amount of loss can be reasonably estimated. The Company, in accordance with this guidance, does not recognize gain contingencies until realized or realizable.
Warrants
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in FASB ASC Topic 480, Distinguishing Liabilities from Equity (ASC 480) and FASB ASC Topic 815, Derivatives and Hedging (ASC 815). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own Common Stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.
| F-9 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2025 AND 2024
For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be liability classified and recorded at their initial fair value on the date of issuance and remeasured at fair value and each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations. The Company generally determines fair value of the Common Stock Warrants using a Black-Scholes valuation methodology.
A change in any of the terms or conditions of warrants is accounted for as a modification. The accounting for incremental fair value of warrants is based on the specific facts and circumstances related to the modification which may result in a reduction of additional paid-in capital, recognition of costs for services rendered, or recognized as a deemed dividend.
Basic loss per share of common stock is computed by dividing net loss attributable to Common Stockholders by the weighted average number of shares of common stock outstanding for the period. Diluted loss per share reflects the potential dilution that could occur if stock options, restricted stock awards and warrants were to vest and be exercised. Diluted earnings per share excludes, when applicable, the potential impact of stock options, common stock warrant shares, convertible notes, and other dilutive instruments because their effect would be anti-dilutive in the periods in which the Company incurs a net loss.
| December 31, | ||||||||
| 2025 | 2024 | |||||||
| Stock options | ||||||||
| Common stock warrants | ||||||||
| Totals | ||||||||
| F-10 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2025 AND 2024
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and are adopted by the Company as of the specified effective date.
In December 2023, the FASB issued Accounting Standards Update (ASU) No. 2023-09 Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which is intended to enhance the transparency and decision usefulness of income tax disclosures, primarily by amending disclosure requirements for the effective tax rate reconciliation and income taxes paid. ASU 2023-09 should be applied on a prospective basis, and retrospective application is permitted. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. Early adoption is permitted. The Company adopted this ASU or the year ended December 31, 2025 (see Note 15 “Income Taxes” for more information).
Recent Accounting Pronouncements Not Yet Adopted
In November 2024, the FASB issued ASU No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”) and in January 2025, the FASB issued ASU No. 2025-01, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date, which clarified the effective date of ASU 2024-03. ASU 2024-03 will require the Company to disclose the amounts of purchases of inventory, employee compensation, depreciation, and intangible asset amortization, as applicable, included in certain expense captions in the Consolidated Statements of Operations, as well as qualitatively describe remaining amounts included in those captions. ASU 2024-03 will also require the Company to disclose both the amount and the Company’s definition of selling expenses. The Company is currently evaluating the impact of adopting of ASU 2024-03.
Management has considered all other recent accounting pronouncements that are issued, but not effective, and it does not believe that they will have a significant impact on the Company’s results of operations or financial position.
Note 2. Going Concern
The
accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern which
contemplates the realization of assets and settlement of liabilities and commitments in the normal course of business. Since
inception, the Company has incurred recurring operating losses and negative cash flows from operations and has no revenues. As of December 31, 2025,
the Company had cash of approximately $
Historically, the Company has been primarily engaged in developing Ketamir-2 and MIRA-55. During these activities, the Company sustained substantial losses. The Company’s ability to fund ongoing operations and future clinical trials required for FDA approval is dependent on the Company’s ability to obtain significant additional external funding in the near term. Since inception, the Company has financed its operations through related party financings — see Note 6, and initial public offering in 2023. The Company maintains an effective shelf registration statement with the SEC for the issuance of shares of common stock under various types of equity offerings, including the shares of common stock under our ATM equity program (See Note 9). The Company expects to be able to fund operations into the first quarter of 2027, with the cash on hand. However, the Company has the ability to issue common stock under its shelf registration statement to assist in liquidity needs.
| F-11 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2025 AND 2024
As of the date of filing this Report, the Company will continue to generate losses and have insufficient cash and cash equivalents on hand to support its operations for at least the 12 months following the date the consolidated financial statements are issued. These factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of twelve months from the issuance date of this report. Management cannot provide assurance that the Company will ultimately achieve profitable operations or become cash flow positive or raise additional debt and/or equity capital. The Company is seeking to raise capital through additional debt and/or equity financings to fund our operations in the future. If the Company is unable to raise additional capital or secure additional lending in the near future, management expects that the Company will need to curtail its operations. These consolidated financial statements do not include any adjustments related to the recoverability and classification of assets or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
Note 3. Prepaid expenses
Prepaid expense and other current assets consisted of the following at the dates indicated:
| December 31, 2025 | December 31, 2024 | |||||||
| Prepaid expense: | ||||||||
| Prepaid insurance | $ | $ | ||||||
| Other prepaid expense | ||||||||
| Total prepaid expenses | $ | $ | ||||||
Note 4. License agreement, related party
MIRALOGX
On November 15, 2023, the Company and MIRALOGX, LLC, a Florida limited liability company (“MIRALOGX”) entered into an exclusive license agreement (the “License Agreement”) to develop and commercialize Ketamir-2, a drug product containing 2-(2- chlorophenyl)-2-(methylamino) cyclopentan-1-one as an active agent in the United States, Canada and Mexico (the “Territory”). The exclusive license in the License Agreement includes the right of the Company to sublicense the licensed intellectual property. The Company and MIRALOGX have the same founder, who is also related to Company’s largest shareholder and thus MIRALOGX is considered a related party.
Pursuant
to the terms of the License Agreement, and subject to the conditions set forth therein, the Company paid MIRALOGX a one-time, nonrefundable
payment of $
Also,
in consideration of the License Agreement, the Company issued to MIRALOGX a Common Stock Purchase Warrant to purchase up to shares
of the Company’s common stock (the “MIRALOGX Warrant”). The MIRALOGX Warrant is exercisable, in whole or in part, any
time prior to November 15, 2028 at a cash exercise price of $
The Company and MIRALOGX have made customary representations and warranties in the License Agreement and have agreed to certain other customary covenants, including confidentiality, cooperation, and indemnity provisions. Either party may terminate the License Agreement for cause if the other party materially breaches or defaults in the performance of its obligations, and, if curable, such material breach remains uncured for 120 days. Unless earlier terminated, the License Agreement will continue in effect until the last to expire of the patent rights licensed pursuant to the License Agreement.
In
the SKNY asset acquisition (See Note 5), the Company acquired the license to SKNY-1, a preclinical drug candidate (the “SKNY License”)
originally licensed from MIRALOGX by SKNY. In acquiring the rights to the SKNY License, the Company gained the rights to commercialize
SKNY-1 in the United States, Canada, and Mexico. Pursuant to the terms of the SKNY License, and subject to the conditions set forth therein,
the Company will be obligated to pay a royalty payment of
| F-12 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2025 AND 2024
Note 5. Asset Acquisition
Acquisition of SKNY Pharmaceuticals, Inc.
On March 19, 2025, we entered
into a binding letter of intent (the “LOI”) with SKNY Pharmaceuticals, Inc. (“SKNY”), a privately held Delaware
corporation, which is a related party due to certain common shareholders and licensor, to acquire SKNY through a stock-for-stock merger
with our merger subsidiary, which we formed on June 13, 2025 (the “Merger”). On September 29, 2025 (the “Closing
Date”), we closed this merger. SKNY was the survivor of this merger and became our wholly owned subsidiary. SKNY’s preclinical
drug candidate, SKNY-1, is designed to modulate CB1, CB2, and MAO-B pathways to address energy storage, lipid metabolism, appetite, cravings,
and reward - without the psychiatric side effects that limited earlier CB1-targeting drugs. SKNY holds exclusive rights in the United
States to its drug candidate under license from Miralogx, a related party of the Company, see Note 3, License Agreement, Related Party.
The transaction was recorded as an asset acquisition from a related party at acquired cost basis with two assets acquired, a license agreement
and shares in common stock of Telomir Pharmaceuticals, Inc. (NASDAQ: TELO), a publicly traded preclinical stage biotechnology
company, which is a related party to MIRA due to certain common ownership, officers and directors. The shares of TELO
common stock were contributed to the Company on behalf of SKNY by SKNY’s largest shareholder. The shares in
TELO represented $
Also on the Closing
date, MIRA issued new
shares in MIRA common stock to the SKNY shareholders (See Notes 6 and 9). The common shares were valued at $
Note 6. Related party transactions
Due from Related Party
Amounts
due from MIRALOGX as of December 31, 2025 and 2024, which are presented as a related party receivable, in the accompanying
consolidated balance sheets, totaled $
Due to Related Party
As
of December 31, 2025, the Company owed an aggregate of $
Asset Acquisition
See Note 5 for asset acquisition from a related party.
License Agreement
See Note 4.
Stock Settled Agreement
See Note 9.
| F-13 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2025 AND 2024
Note 7. Commitments and contingencies
In the ordinary course of business, the Company enters into various agreements containing standard indemnification provisions. The Company’s indemnification obligations under such provisions are typically in effect from the date of execution of the applicable agreement through the end of the applicable statute of limitations. The aggregate maximum potential future liability of the Company under such indemnification provisions is uncertain. As of December 31, 2025 and 2024, no amounts have been accrued related to such indemnification provisions.
From time to time, the Company may be exposed to litigation in connection with its operations. The Company’s policy is to assess the likelihood of any adverse judgments or outcomes related to legal matters, as well as ranges of probable losses.
The Company’s former corporate headquarters were located in Baltimore, Maryland, which included a lease for office space. This lease began in November 2021 and ended April 2024. The lease was not renewed after April 2024. In April 2024, the Company moved to a virtual office model and does not have a physical office space as of December 31, 2025 nor 2024.
The Company had leased an
office in Tampa, Florida, for its finance and general operations, which began in March 2022 for 37 months. On December 1, 2023, the Company
formally terminated the lease with the landlord. There was a remaining deposit due from the landlord to the Company of $
Variable lease costs
Variable lease costs primarily include utilities, property taxes, and other operating costs that are passed on from the lessor.
| For the year ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Lease costs | ||||||||
| Operating lease costs | $ | $ | ||||||
| Variable lease costs | ||||||||
| Total lease cost | $ | $ | ||||||
Supplemental cash flow information related to leases was as follows:
| For the year ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Other lease information | ||||||||
| Cash paid for amounts included in the measurement of lease liabilities | ||||||||
| Operating cash flows from operating leases | $ | $ | ||||||
| F-14 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2025 AND 2024
Note 8. Income taxes
The Company elected to prospectively
adopt the guidance in ASU No. 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures.” The following table
reconciles the U.S. federal statutory income tax rate of
The following table reconcile the U.S. Federal statutory income tax rate to the Company’s effective income tax rate for years ended December 31, 2025 and 2024:
| Year ended December 31, | ||||||||||||||||
| 2025 | 2024 | |||||||||||||||
| Amount | Rate | Amount | Rate | |||||||||||||
| Components of loss before provision for income taxes | $ | — | $ | — | ||||||||||||
| Provision for income taxes at U.S. federal statutory rate | $ | ( | ) | % | $ | ( | ) | % | ||||||||
| State and local income taxes, net of federal benefit | ( | )% | ( | ) | )% | |||||||||||
| Change in Valuation Allowance | ( | )% | ( | )% | ||||||||||||
| Other permanent items | ( | )% | ( | ) | % | |||||||||||
| Other adjustments | ( | )% | % | |||||||||||||
| Total tax provision and effective tax rate | $ | % | $ | % | ||||||||||||
The significant components of the Company’s net deferred tax assets are as follows:
As of December 31, | ||||||||
| 2025 | 2024 | |||||||
| Deferred tax assets | ||||||||
| Net operating loss carry-forward | $ | $ | ||||||
| Section 174 Qualified Research Expenditures | ||||||||
| Stock compensation | ||||||||
| R&D Credit | ||||||||
| Other | ||||||||
| Deferred tax assets, Gross | ||||||||
| Less: valuation allowance | ( | ) | ( | ) | ||||
| Total net deferred tax asset | $ | $ | ||||||
Beginning
in 2022, in accordance with Internal Revenue Code Section 174, Qualified Research Expenditures are capitalized for tax purposes and amortized
over a period of five years. Accordingly, for income tax purposes, and as of December 31, 2025 and December 31, 2024, the Company has
recorded a deferred tax asset totaling approximately $
The components of the provision for income taxes consist of the following:
| December 31, | ||||||||
| 2025 | 2024 | |||||||
| Deferred tax: | ||||||||
| Deferred | ( | ) | ( | ) | ||||
| Change in valuation allowance | ||||||||
| Total deferred | ||||||||
| Total provision for income taxes | $ | $ | ||||||
ASC
Topic 740 requires that a deferred tax amount be reduced by a valuation allowance if, based on the weight of available evidence it is
more likely than not (a likelihood of more than 50%) that some portion or all of the deferred tax assets will not be realized. The valuation
allowance should be sufficient to reduce the deferred tax asset to the amount that is more likely than not to be realized. The Company
has recorded a full valuation allowance against its deferred tax assets generated by net operating loss carryforwards as it has determined
that such amounts may not be recognizable, given the historical losses of the Company to date. As of December 31, 2025, the Company has
a cumulative federal net operating loss carryforward of approximately $
| F-15 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2025 AND 2024
Note 9. Stockholders’ equity
Capital stock
The Company has the authority
to issue
Common Stock sold under ATM
On
August 12, 2024, the Company filed a shelf registration statement with the SEC to facilitate the issuance of our common stock and entered
into an At-the-Market Offering Agreement (the “ATM Agreement”) with Rodman & Renshaw LLC, under which the Company may
offer and sell shares of its Common Stock, with an aggregate offering amount sold of up to $
During
the year ended December 31, 2025, under the ATM Agreement, the Company sold and issued shares of Common Stock at an
average price per share of $ and received net proceeds of $
Common Stock issued for Acquisition
On
September 29, 2025, in connection with acquisition of SKNY Pharmaceuticals, Inc. (See Note 5), the Company issued new shares
in Company Common Stock to the SKNY shareholders. The common shares were valued at $
Stock settlement agreement
On
April 24, 2024 the Company settled a claim submitted by certain shareholders under Section 16 of the Securities Exchange Act involving
the Company that claimed illegal profits were earned on stock transactions involving insiders of the Company. After investigation, the
Company informed the insider, Bay Shore Trust, of the claim and came to agreement with the shareholders, requiring the disgorgement
of profits by the insider back to the Company in the amount of $
Common Stock issued upon stock option exercise
During the year ended December 31, 2025, former and current executives of the Company exercised outstanding stock options to acquire an aggregate of shares of the Company’s common stock. The Company received net cash proceeds of $ in connection with these option exercises. There were no stock options exercised during the year ended December 31, 2024.
Common Stock issued for vested RSUs
During the year ended December 31, 2025, a total of restricted stock units were vested, resulting in the issuance of shares of common stock. During the year ended December 31, 2024, no common stock was issued in as a result of vesting of restricted stock units.
2022 Omnibus Incentive Plan
In June 2022, the Company’s Board of Directors adopted, and its stockholders approved, the Company’s 2022 Omnibus Incentive Plan, as amended and restated in August 2023, (“2022 Omnibus Plan”). The 2022 Omnibus Plan authorizes the grant of incentive stock options, within the meaning of Section 422 of the Internal Revenue Code, to the Company’s employees and any of its parent and subsidiary corporations’ employees, and for the grant of non-statutory stock options, restricted stock, restricted stock units, stock appreciation rights, performance units and performance shares to the Company’s employees, directors, and consultants and any of its future subsidiary corporations’ employees and consultants. On September 11, 2025, the Company held its 2025 Annual Meeting of Stockholders (the “Annual Meeting”) in which it was voted upon to increase the shares provided under the plan from shares to shares. In addition, the number of shares available for issuance under the Plan includes an annual increase on the first day of each fiscal year equal to the lesser of (a) shares, (b)% of the outstanding shares of all classes of our common stock as of the last day of the immediately preceding fiscal year, or (c) such other amount as the Company’s board of directors may determine.
As of December 31, 2025, the 2022 Omnibus Plan provides that shares of the Company’s Common Stock are reserved for issuance under the 2022 Omnibus Plan, all of which may be issued pursuant to the exercise of incentive stock options.
| F-16 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2025 AND 2024
Stock-based compensation
The fair value of each option award is estimated on the grant date using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate. Historically, the Company estimated expected price volatility based on the historical volatilities of a peer group as the Company did not have a multi-year trading history for its shares. Industry peers consist of several public companies in the biotech industry similar to the Company in size, stage of life cycle, and product indications. In September 2025, the Company commenced using the historical volatility of its shares as an estimate of expected share price volatility.
Expected term of options granted is derived using the “simplified method” which computes expected term as the average of the sum of the vesting term plus contract term. The risk-free rate is based on the 5-year U.S. Treasury yield curve in effect at the time of grant. The Company recognizes forfeitures as they occur.
During
the year ended December 31, 2025, a total of options to purchase Common Stock, with an aggregate fair market value of approximately
$
During
the year ended December 31, 2024, a total of options to purchase Common Stock, with an aggregate fair market value of approximately
$
| Number of Shares | Weighted Average Exercise Price Per Share | Weighted Average Remaining Contractual Life (Years) | Aggregate Intrinsic Value | |||||||||||||
| Outstanding as of December 31, 2023 | $ | $ | ||||||||||||||
| Granted | — | — | ||||||||||||||
| Expired | ( | ) | — | — | ||||||||||||
| Forfeitures | ( | ) | — | — | ||||||||||||
| Outstanding as of December 31, 2024 | $ | $ | ||||||||||||||
| Granted | — | — | ||||||||||||||
| Exercised | ( | ) | — | — | ||||||||||||
| Expired | ( | ) | — | — | ||||||||||||
| Forfeitures | ( | ) | — | — | ||||||||||||
| Outstanding as of December 31, 2025 | ||||||||||||||||
| Exercisable as of December 31, 2025 | $ | $ | 1,042,000 | |||||||||||||
The Company recognized approximately $ million and $ million in stock-based compensation when includes compensation for stock options and vested RSUs in 2025 and 2024, respectively. The weighted average grant-date fair values of options granted during the years ended December 31, 2025 and 2024 were $ and $ per share, respectively. As of December 31, 2025, there is approximately $ of unrecognized compensation cost related to unvested stock options granted under the Company’s 2022 Plan that is expected to be recognized over the next year.
| F-17 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2025 AND 2024
| Years Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Risk-free interest rate | - | % | - | % | ||||
| Expected volatility | - | % | - | % | ||||
| Exercise Price | $ | - $ | $ | - $ | ||||
| Expected term (years) | - years | - years | ||||||
| Dividend yield | — | — | ||||||
On
September 15, 2025, the compensation committee of the Company voted to reprice the exercise price of certain stock options
previously granted to the Chief Executive Officer, Erez Aminov. In total,
stock options were repriced from $
On
July 15, 2025, Michelle Yanez, the Company’s former Chief Financial Officer, exercised options to purchase shares of the
Company’s common stock. The Company received $
On
September 12, 2025, Michelle Yanez exercised options to purchase shares of the Company’s common stock. The Company received
$
On
September 22, 2025, a former company employee exercised options to purchase shares of the Company’s common stock. The Company
received $
On
October 16, 2025, Erez Aminov, the Company’s Chairman and Chief Executive Officer, exercised options to purchase shares
of the Company’s common stock. The Company received $
Restricted Stock Units
During
the year ended December 31, 2024, a total of restricted stock units (“RSU”), with an aggregate fair market value
of approximately $ million were granted to the Company’s Chief Executive Officer under the 2022 Omnibus Incentive Plan. These
RSU’s vest as follows: (i)
On March 26, 2025, the compensation committee of the Company adopted the Company’s Executive Incentive Compensation Plan (the “EICP”) for Erez Aminov, its Chairman and Chief Executive Officer. Under the EICP, Mr. Aminov will be eligible for certain long-term awards of up to performance-based and market condition-based restricted stock units of the Company’s common stock, par value $ upon the Company achieving specified milestones based upon the Company reaching certain market capitalization values and the progress of the Company’s drug candidates. All awards under the EICP are subject to the approval of the Board and the Committee. Furthermore, the Board and the Committee, each in its sole discretion, generally retain the right to amend, supplement, supersede or cancel any awards under the EICP for any reason, and reserve the right to determine whether and when to pay out any bonus amounts pursuant to or outside of the EICP, regardless of the achievement of the performance targets.
On July 18, 2025, the Board and the Committee determined the Market
capitalization threshold of $
| F-18 |
MIRA PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2025 AND 2024
| Number of Restricted Shares | ||||
| Unvested as December 31, 2024 | ||||
| Granted | ||||
| Expired and forfeitures | ||||
| Vested | ( | ) | ||
| Unvested as December 31, 2025 | ||||
Warrants
In connection with various transactions and the IPO summarized below, the Company issue stock warrants. Warrant activity for the year ended December 31, 2025 is summarized below:
| Weighted | ||||||||||||||||
| Weighted | Average | |||||||||||||||
| Number of | Average Exercise | Remaining Contractual | Aggregate | |||||||||||||
| Warrants | Price | Term (Years) | Intrinsic Value | |||||||||||||
| Balance Outstanding as December 31, 2024 | $ | $ | ||||||||||||||
| Granted | — | — | — | |||||||||||||
| Exercised | — | — | — | |||||||||||||
| Balance outstanding as December 31, 2025 | $ | $ | ||||||||||||||
| Exercisable, December 31, 2025 | $ | $ | ||||||||||||||
Note 10. Segment Information
The Company operates in one reportable segment related to the development and commercialization of pharmaceuticals targeting neurologic and neuropsychiatric disorders. The CODM for the Company is the Chief Executive Officer (the “CEO”). The Company’s CEO reviews operating results on an aggregate basis and manages the Company’s operations as a whole for the purpose of evaluating financial performance and allocating resources. Accordingly, the Company has determined that it has a single reportable and operating segment structure. The CEO uses aggregate net loss to allocate resources in the annual budgeting and forecasting process and also uses that measure as a basis for evaluating financial performance regularly by comparing actual results with established budgets and forecasts.
The accounting policies of the Company’s single segment are the same as those described in the summary of significant accounting policies within Note 1. The CEO assesses performance for the Company and decides how to allocate resources based on the aggregate net loss that is also reported on the income statement as net loss. The measure of segment assets is reported on the balance sheets as total assets.
The table below provides information about the Company’s revenue, significant segment expenses and other segment expenses.
| Year Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenues | $ | $ | ||||||
| Operating costs: | ||||||||
| General and administrative expenses | ||||||||
| Research and development expenses | ||||||||
| Total operating costs | ||||||||
| Other income (expense): | ||||||||
| Interest income | ||||||||
| Other expense | ( | ) | ||||||
| Unrealized loss on short-term investment | ( | ) | ||||||
| Total other income, net | ||||||||
| Segment net loss | ( | ) | ( | ) | ||||
Note 11. Subsequent Events
On
March 29, 2026, the Board and the Committee determined the certain milestone in Company’s Phase I clinical trial had been achieved.
As a result, on March 29, 2026, the grant date, the Company issued Erez Aminov $
| F-19 |
Item 9. Changes In and Disagreements with Accountants on Accounting and Financial Disclosure.
None.
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, our Chief Executive Officer (our principal executive officer) and our Chief Financial Officer (our principal financial officer) (the “Certifying Officers”), has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) under the Exchange Act) as of December 31, 2025. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by the company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal accounting officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. The Certifying Officers have concluded, based on their evaluation as of the end of the period covered by this Report, that our disclosure controls and procedures were effective to provide reasonable assurance that the objectives of our disclosure control system were met.
Management’s Annual Report on Internal Control over Financial Reporting
Management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Section 13a-15(f) of the Securities Exchange Act of 1934, as amended). Internal control over financial reporting is a process designed by, or under the supervision of, the Company’s principal financial officer to provide reasonable assurance regarding the reliability of financial reporting and the preparation of the Company’s financial statements for external reporting purposes in conformity with U.S. generally accepted accounting principles and include those policies and procedures that (i) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and disposition of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of consolidated financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorization of management and directors of the Company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the consolidated financial statements. During 2024, we designed and implemented new and enhanced controls to strengthen our internal controls over financial reporting, including hiring additional experienced accounting personnel, among other enhancements. Management believes these enhancements were sufficient to remediate previously identified material weaknesses.
As of December 31, 2025, management conducted an assessment of the effectiveness of the Company’s internal control over financial reporting based on the framework established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations (COSO) of the Treadway Commission. Based on the criteria established by COSO management concluded that the Company’s internal control over financial reporting was effective as of December 31, 2025.
| 62 |
This Report does not include an attestation report of the Company’s independent registered public accounting firm regarding internal control over financial reporting as smaller reporting companies are not required to include such report and emerging growth companies (“EGC’s”) are exempt from this requirement entirely until they are no longer an EGC. Management’s report is not subject to attestation by the Company’s independent registered public accounting firm.
Changes in Internal Control over Financial Reporting
There were no additional changes in our internal control over financial reporting (as defined in Rule 13(a)-15(f) of the Exchange Act) that occurred during the period covered by this annual report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
PART III
Item 10. Directors, Executive Officers and Corporate Governance.
Our directors and executive officers and their ages as of the date of this Report are as follows:
| Name | Age | Position | ||
| Erez Aminov | 48 | Chief Executive Officer and Chairman | ||
| Alan Weichselbaum | 61 | Chief Financial Officer and Treasurer | ||
| Matthew Pratt Whalen | 47 | Director | ||
| Matthew Paul Del Giudice, M.D. | 44 | Director | ||
| Denil Nanji Shekhat, M.D. | 45 | Director | ||
| Edward MacPherson | 38 | Director |
The following is a brief biography of each of our current executive officers and directors:
Erez Aminov has served as a director and our Chief Executive Officer since April 2023 and our Chairman since March 2024. Mr. Aminov is an experienced biotechnology consultant and investor and initially joined our as a consultant in 2022. Mr. Aminov’s experience in the biotech consulting sector began in 2021 when he founded Locate Venture Corp. in September 2021. Locate Venture is a strategy and investment consulting firm focused on advancing and supporting early-stage biotech startups. Prior to founding Locate Venture Corp., from February 2015 to September 2020, Mr. Aminov served as the President of Finds4less Inc., a global distributor of electronics and gaming products. In this role, Mr. Aminov provided strategic oversight and direction for all aspects of the company’s operations, while also spearheading new business development initiatives to capitalize on emerging market opportunities. Mr. Aminov’s more than two decades of experience includes experience with the biotech industry’s particular challenges, including creating strategic alliances and guiding startups toward growth and prosperity. Mr. Aminov earned a B.A. in Accounting from Touro University in New York. We believe that Mr. Aminov is qualified to serve as one of our directors based on his finance and investment experience, particularly with early-stage life sciences companies. Mr. Aminov is also the Chief Executive Officer of Telomir Pharmaceuticals, Inc. (Nasdaq: TELO).
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Alan Weichselbaum, CPA, MBA, Chief Financial Officer of the Company since May 2025, brings over 30 years of experience in corporate finance, capital markets, and strategic advisory across multiple industries. He plays a key leadership role in advancing the financial and strategic objectives of both companies as they pursue growth through drug development, licensing, and potential M&A opportunities. Mr. Weichselbaum serves as the Chief Financial Officer of Telomir Pharmaceuticals, Inc. since May 2025. Additionally, since 2015, Mr. Weichselbaum has served as a director of FinWise Bancorp (Nasdaq: FINW), providing oversight and strategic direction to the publicly traded financial institution. In 2011, he founded The Wexus Group, an outsourced CFO advisory firm that partners with small and mid-sized companies to support growth, capital structuring, and exit strategies across various sectors. From 1995 to 2010, he held senior roles on Wall Street, where he served as an equity analyst, managed two hedge funds, and was Chief Executive Officer of a boutique brokerage firm. His capital markets expertise and experience leading institutional transactions have positioned him as a trusted advisor in both public and private markets. Earlier in his career, Mr. Weichselbaum was Manager of Budgeting and Financial Analysis at Philip Morris Capital Corporation. He began his professional journey at Price Waterhouse in 1985, working in the firm’s small business division before pursuing graduate studies. Mr. Weichselbaum earned his MBA in Finance from New York University and is a Certified Public Accountant licensed in the State of New York. His deep financial acumen, combined with extensive experience in investor relations, capital formation, and M&A, makes him a vital member of the executive leadership at MIRA Pharmaceuticals, Inc.
Matthew Pratt Whalen, CPA, is a Certified Public Accountant with over two decades of experience in public accounting and corporate finance. Mr. Whalen currently serves as the Chief Financial Officer of Power Digital Marketing Inc., an industry leading digital marketing agency, where he has driven significant revenue growth and led key financial transactions. Specifically, Mr. Whalen oversees the finance team, manages tax and audit relationships, and handles treasury management. Prior to joining Power Digital, from 2010 to May 2021, Mr. Whalen was the Chief Financial Officer of MRC Smart Technology Solutions, a subsidiary of Xerox Corporation where he played a pivotal role in growing the company’s revenue and managed diverse teams across multiple departments. Mr. Whalen holds a B.A. in Accounting from the University of San Diego and is a Certified Public Accountant in California. Mr. Whalen has also served on the Finance Committee of United Way San Diego. We believe that Mr. Whalen is qualified to serve as one of our directors based on his extensive experience in finance and as a Certified Public Accountant. Mr. Whalen also serves as a director of Telomir Pharmaceuticals, Inc. (Nasdaq TELO).
Dr. Matthew Paul Del Giudice joined our company as a director in March 2024. Dr. Del Giudice has practiced as a radiologist since 2014. He currently serves as a general overnight emergency radiologist at the Cleveland Clinic and as a real estate investor with Comfort Living, LLC. Prior to joining the Cleveland Clinic, from March 2021 to May 2022, Dr. Del Giudice was a general radiologist with Radiology and Imaging Specialists in Lakeland, Florida. From July 2015 to February 2021, Dr. Del Giudice was a radiologist with Radiology Partners Phoenix, and from July 2014 to June 2015, he practiced as a musculoskeletal radiologist at the University of Arizona Health Sciences Center - Tucson. Dr. Del Giudice received his B.S. from the University of Illinois at Urbana-Champaign, his M.D. from Loyola University Stritch School of Medicine, completed his radiology residency at Loyola University Medical Center, and his musculoskeletal radiology fellowship at the University of Arizona Health Sciences Center - Tucson. Dr. Del Giudice is licensed to practice medicine in Florida and Ohio. Dr. Del Giudice also serves as a director of Telomir Pharmaceuticals, Inc. (Nasdaq TELO).
Dr. Denil Nanji Shekhat joined our company as a director in March 2024. Dr. Shekhat has practiced as a radiologist since 2014 and currently practices at DNS Teleradiology in Wellington, Florida. Prior to starting DNS Teleradiology, Dr. Shekhat was a musculoskeletal specialist for Radiology Associates of Florida/ Radiology Partners from July 2018 to December 2023. From July 2015 to August 2018, Dr. Shekhat practiced as a general and musculoskeletal radiologist with Bethesda Radiology Associates. Dr. Shekhat received his B.A. in economics from Bowdoin College, his M.D. from the University of Tennessee Health Science Center, College of Medicine, completed his radiology residency at Baptist Memorial Hospital and his musculoskeletal radiology fellowship at the University of Arizona. Dr. Shekhat is currently licensed to practice medicine in Florida.
Edward MacPherson joined our company as a director in March 2024. Mr. MacPerson currently serves as Chief Growth Officer for Power Digital, an industry leading digital marketing agency. Prior to joining Power Digital, from May 2016 to December 2023, he served as CEO and Head of Growth for Endrock Growth & Analytics, a company he founded and sold to Power Digital. Prior to founding Endrock Growth & Analytics, Mr. MacPherson held senior marketing and leadership positions at sunglass maker Prive Revaux (March 2018 to April 2020), curated meal company Menud (October 2014 to April 2018) and Rejuvenetics, LLC, a distributor of health and wellness products (December 2012 to March 2016). Mr. Macpherson holds a BA in Economics from Gettysburg College. Mr. MacPherson also serves as a director of Telomir Pharmaceuticals, Inc. (Nasdaq TELO).
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Key Consultants
On March 8, 2024, and subsequently amended on January 24, 2025, we entered into an Amended and Restated Consulting Agreement with Angel Pharmaceutical Consulting & Technologies Ltd., an Israeli consulting firm (“APCT”). All services provided to our company by APCT (which began in October 2023) are provided directly by Dr. Itzchak Angel, who shall be our Chief Scientific Advisor. Dr. Angel has over 30 years of experience in the pharmaceutical industry, guiding strategic drug and business development initiatives in both large and emerging companies.
Dr. Angel has served as Head of Pharmacology of Synthelabo (Paris, France, now Sanofi) for numerous years, where he was instrumental in the development and bringing into the market of several drugs such as Xatral (Alfuzosin), Ambien (Zolpidem) and Mizollen (Mizolastine). He formerly served as President and Chief Executive Officer of stem-cell company Accellta (Haifa, Israel) and Vice President for Research and Development at Proteologics Ltd, and at D-Pharm Biopharmaceuticals (Rehovot, Israel) where he developed several neurology compounds (stroke, Alzheimer’s and Parkinson’s Disease) into advanced clinical development and was involved in submitting numerous INDs of drugs under development. Dr. Angel is the author of more than 100 book chapters, papers, and abstracts as well as the named inventor of a number of pharmaceutical patents. Dr. Angel received his B.S. and M.Sc. in Biology from Tel-Aviv University, Israel, cum laude in 1979, and received Ph.D. cum laude from the Hamburg University, Germany in 1982.
As part of his consulting services, Dr. Angel shall assist our company with (i) pharmaceutical regulatory affairs, toxicology, drug research and pre-clinical and clinical testing, (ii) outsourcing and helping our company in managing third party vendors and (iii) working with our company in our interactions with regulatory bodies.
Board Composition
Our business and affairs are managed under the direction of our board of directors, which currently consists of five members. The number of directors is determined by our board of directors, subject to the terms of our amended and restated articles of incorporation and bylaws that. Our directors are elected for one-year terms.
Family Relationships
There are no family relationships among any of our directors and executive officers.
Director Independence
Our board of directors has undertaken a review of the independence of each director. Based on information provided by each director concerning his or her background, employment, and affiliations, our board of directors has determined that Matthew Whalen, Dr. Matthew Del Giudice, Dr. Denil Shekhat and Edward MacPherson do not have any relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director and are independent directors under the Nasdaq Listing Rules.
In making these determinations, our board of directors considered the current and prior relationships that each non-employee director has with our company and all other facts and circumstances our board of directors deemed relevant in determining their independence, including the transactions described in the section of this Report titled “Item 13. Certain Relationships and Related Party Transactions.”
Committees of the Board of Directors
Our board of directors has established an audit committee, a compensation committee, and a nominating and corporate governance committee. The functions of these committees are described below. Members will serve on these committees until their resignation or until otherwise determined by our board of directors. Our board of directors may establish other committees as it deems necessary or appropriate from time to time.
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Audit Committee
Our audit committee consists of Matthew Whalen, Dr. Denil Shekhat and Edward MacPherson, with Matthew Whalen serving as the chair of the audit committee. Each member of the committee meets the requirements for independence under the listing standards of Nasdaq and SEC rules and regulations, including Rule 10A-3(b)(1) under the Exchange Act. Each member of our audit committee also meets the financial literacy requirements of the listing standards of Nasdaq. In addition, our board of directors has determined that Michael Jerman is an audit committee financial expert within the meaning of Item 407(d) of Regulation S-K under the Securities Act.
The audit committee’s main purpose is to oversee our corporate accounting and financial reporting process. Our audit committee is responsible for, among other things:
| ● | selecting a qualified firm to serve as the independent registered public accounting firm to audit our financial statements; |
| ● | helping to ensure the independence and performance of the independent registered public accounting firm; |
| ● | discussing the scope and results of the audit with the independent registered public accounting firm, and reviewing, with management and the independent registered public accounting firm, our interim and year-end results of operations; |
| ● | developing procedures for employees to submit concerns anonymously about questionable accounting or audit matters; |
| ● | reviewing our policies on risk assessment and risk management; |
| ● | reviewing related party transactions; |
| ● | reviewing and pre-approving, as required, all audit and all permissible non-audit services to be performed by the independent registered public accounting firm; and |
| ● | assisting our board of directors in monitoring the performance of our internal audit function. |
Our audit committee operates under a written charter that satisfies the applicable rules and regulations of the SEC and the listing standards of Nasdaq, a copy of which is available on our website at www.mirapharmaceuticals.com.
Compensation Committee
Our compensation committee consists of Dr. Denil Shekhat and Edward MacPherson, with Dr. Denil Shekhat serving as the chair of the compensation committee. Each member of the committee meets the requirements for independence under the listing standards of Nasdaq and SEC rules and regulations. Each member of our compensation committee is also a non-employee director, as defined pursuant to Rule 16b-3 promulgated under the Exchange Act, or Rule 16b-3. In arriving at these determinations, our board of directors examined all factors relevant to determining whether any compensation committee member has a relationship to us that is material to that member’s ability to be independent from management in connection with carrying out such member’s duties as a compensation committee member.
The compensation committee’s main purpose is to review and recommend policies relating to compensation and benefits of our officers and employees. Our compensation committee is responsible for, among other things:
| ● | reviewing, approving, and determining, or making recommendations to our board of directors regarding, the compensation and compensation arrangements of our executive officers; |
| ● | administering our equity compensation plans; |
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| ● | reviewing and approving, or making recommendations to our board of directors regarding, incentive compensation and equity compensation plans; and |
| ● | establishing and reviewing general policies relating to compensation and benefits of our employees. |
Our compensation committee operates under a written charter that satisfies the applicable rules and regulations of the SEC and the listing standards of Nasdaq, a copy of which is available on our website.
Nominating and Corporate Governance Committee
Our nominating and corporate governance committee consists of Dr. Matthew Del Giudice and Dr. Denil Shekhat with Dr. Matthew Del Giudice serving as the chair of the nominating and corporate governance committee. Each member of the committee meets the requirements for independence under the listing standards of Nasdaq and SEC rules and regulations.
Our nominating and corporate governance committee is responsible for, among other things:
| ● | identifying, evaluating, and selecting, or making recommendations to our board of directors regarding, nominees for election to our board of directors and its committees; |
| ● | developing and overseeing the annual evaluation of our board of directors and of its committees; |
| ● | considering and making recommendations to our board of directors regarding the composition of our board of directors and its committees; |
| ● | overseeing our corporate governance practices; and |
| ● | making recommendations to our board of directors regarding corporate governance guidelines. |
Our nominating and corporate governance committee operates under a written charter that satisfies the applicable listing standards of Nasdaq, a copy of which is available on our website.
Compensation Committee Interlocks and Insider Participation
None of the members of our compensation committee is a current or former executive officer or employee of our company. None of our executive officers serves as a member of the compensation committee of any entity that has one or more executive officers serving on our compensation committee.
Risk Oversight
One of the key functions of our board of directors is informed oversight of our risk management process. Our board of directors administers this oversight function directly through our board of directors as a whole, and through various standing committees of our board of directors that address risks inherent in their respective areas of oversight. In particular, our board of directors is responsible for monitoring and assessing strategic risk exposure, including risks associated with cybersecurity and data protection, and our audit committee has the responsibility to consider our major financial risk exposures and the steps our management has taken to monitor and control these exposures, including guidelines and policies to govern the process by which risk assessment and management is undertaken. Our audit committee will review legal, regulatory, and compliance matters that could have a significant impact on our financial statements. Our nominating and corporate governance committee will monitor the effectiveness of our corporate governance practices, including whether they are successful in preventing illegal or improper liability-creating conduct. Our compensation committee will assess and monitor whether any of our compensation policies and programs has the potential to encourage excessive risk taking. While each committee is responsible for evaluating certain risks and overseeing the management of such risks, our entire board of directors will be regularly informed through committee reports about such risks.
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Code of Business Conduct and Ethics
Our board of directors has adopted a code of business conduct and ethics applicable to all of our directors, officers (including our principal executive officer, principal financial officer, and principal accounting officer) and all global employees in accordance with applicable federal securities laws and corporate governance rules of the Nasdaq Capital Market. Our code of business conduct and ethics is available on our website. Any amendments to the code of business conduct and ethics, or waivers of its requirements, will, if required, be disclosed on our website.
Insider Trading Policy
Our
board of directors has
Corporate Governance Guidelines
Our board of directors has adopted corporate governance guidelines, a copy of which is available on our website.
Director Compensation
We did not provide any cash compensation to any of our directors during the year ended December 31, 2025 in their capacity as directors.
Item 11. Executive Compensation
This section discusses the material components of the executive compensation program for the following persons: (i) all persons serving as our principal executive officers during 2025 and (ii) the most highly compensated of our other executive officers who received compensation during 2025 of at least $100,000 and who were executive officers on December 31, 2025. We refer to these persons as our “named executive officers” elsewhere in this Report. Our “named executive officers” and their positions are as follows:
| ● | Erez Aminov, Chief Executive Officer and Chairman; | |
| ● | Alan Weichselbaum, Chief Financial Officer and Treasurer; | |
| ● | Michelle Yanez, Former Chief Financial Officer and Treasurer. |
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Summary Compensation Table
The following table shows the compensation paid by us during the 2025 and 2024 fiscal years to our named executive officers.
| Name and principal position | Year | Salary ($) | Bonus ($) | Stock Awards ($) | Option Awards ($) (6) | Non-Equity Incentive Plan Compensation ($) | Nonqualified Deferred Compensation Earnings ($) | All Other Compensation ($) | Total ($) | |||||||||||||||||||||||||
| Erez Aminov, | 2025 | 438,750 | (1) | 242,258 | (2) | 184,375 | (3) | 4,419,117 | (4) |
- | - | 19,674 | (5) | 5,304,174 | ||||||||||||||||||||
| CEO | 2024 | 259,999 | 300,000 | (2) | 594,950 | (3) | 1,919,120 | (4) | - | - | 66,194 | (5) | 3,140,313 | |||||||||||||||||||||
| Alan Weichselbaum, | 2025 | 37,000 | (6) | - | - | 87,300 | (6) | - | - | 124,300 | ||||||||||||||||||||||||
| CFO | 2024 | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||
| Michelle Yanez, | 2025 | 104,712 | (7) | - | - | - | - | - | 12,000 | (8) | 104,712 | |||||||||||||||||||||||
| Former CFO | 2024 | 158,219 | - | - | 258,900 | (8) | - | - | 26,902 | (8) | 444,021 | |||||||||||||||||||||||
| (1) | On March 26, 2025, Mr. Aminov’s salary was increased to $485,000, effective April 1, 2025. |
| (2) | The 2024 bonus amounts represent bonus earned as part of the CEO Executive Scorecard. The 2025 bonus represents a cash bonus of $242,258, comprising a Capital Raise Bonus of $161,505 and a Strategic / M&A Achievement Bonus of $80,753, according to recommendations in the 2025 Executive Compensation & Short and Long-Term Incentive Plans Revised Report, prepared by the Company’s compensation consultant. |
| (3) | On December 6, 2024, Mr. Aminov was awarded a stock award valued at $594,950, with time-based vesting. During 2025, following the Board’s and Committee’s determinations that the $25 million market capitalization threshold was achieved on July 18, 2025 and the $50 million market capitalization threshold was achieved on December 16, 2025, the Company issued to Mr. Aminov, on the respective grant dates of August 15, 2025 and December 12, 2025, 62,500 fully vested restricted stock units for each grant, with the restricted stock units having aggregate fair market values of $93,750 and $90,625, respectively. |
| (4) | On December 6, 2024, Mr. Aminov was awarded an option award valued at $1,919,120. On December 16, 2025, Mr. Aminov was awarded an option award valued at $4,419,117. |
| (5) | Amount represents health insurance premiums paid, car payments, car insurance, and club memberships. |
| (6) | Mr. Weichselbaum was appointed as our Chief Financial Officer and Treasurer on May 19, 2025. Under the Employment Agreement with Mr. Weichselbaum dated May 15, 2025, Mr. Weichselbaum’s annual salary is $60,000. On May 13, 2025, Mr. Weichselbaum was granted an option award valued at $87,300. |
| (7) | Ms. Yanez served as our Chief Financial Officer and Treasurer until May 19, 2025. The compensation for Ms. Yanez in 2025 included her severance of $53,149, which was paid according to her Separation Agreement dated May 20, 2025. |
| (8) | Amount represents health insurance premiums paid. |
The reported option award amounts represent the aggregate grant date fair value of the awards , computed in accordance with Financial Accounting Standards Board Account Standards Codification Topic 718, Stock Compensation, as modified or supplemented, or FASB ASC Topic 718. The assumptions used in calculating the grant date fair value of the stock options reported in this column are set forth in Note 9 to our Consolidated Financial Statements for the year ended December 31, 2025 included in this Report.
Narrative Disclosure to Summary Compensation Table
Employment Agreements
Except as set forth below, we currently have no written employment agreements with any of our named executive officers.
Erez Aminov
Effective April 28, 2023, we entered into an employment agreement with Mr. Aminov, as amended on August 28, 2023, pursuant to which Mr. Aminov will serve as our Chief Executive Officer. Under his employment agreement, as amended, Mr. Aminov has agreed to devote at least 50% of his business time to the affairs of the Company. Mr. Aminov’s employment agreement provides that his employment will be on an at-will basis and can be terminated by either Mr. Aminov or our company at any time and for any reason. Under the agreement, Mr. Aminov will receive a base salary of $0.2 million per year, effective August 1, 2023. On April 1, 2025, Mr. Aminov’s salary was increased to $485,000.
In the event that Mr. Aminov’s employment is terminated by our company without “Cause” or is terminated by Mr. Aminov for “Good Reason”, Mr. Aminov will be entitled to severance compensation in the form of salary continuation for a period of three months (subject to Mr. Aminov executing and delivering a customary general release in favor of the company). “Cause” is defined in the agreement to include dishonesty, misappropriation, willful misconduct, breach of the agreement, and other customary matters. “Good Reason” is defined to include a material adverse change in Mr. Aminov’s compensation or duties and level of responsibility. The employment agreement also contains customary confidentiality and invention-assignment covenants to which Mr. Aminov is subject.
On March 26, 2025, the Compensation Committee of the Board of Directors approved an increase to Mr. Aminov’s base salary to $485,000, effective April 1, 2025.
On December 16, 2025, the Compensation Committee of the Board of Directors approved a cash bonus of $242,258 for Mr. Aminov, comprising a Capital Raise Bonus of $161,505 and a Strategic / M&A Achievement Bonus of $80,753, according to recommendations in the 2025 Executive Compensation & Short and Long-Term Incentive Plans Revised Report, prepared by the Company’s compensation consultant.
In March 2024, Mr. Aminov assumed the role of Chairman and on March 25, 2024, the Compensation Committee of the Board of Directors approved an increase to Mr. Aminov’s base salary of $0.08 million, bringing his total annual base salary to $0.28 million.
On December 2nd, 2024, the Compensation Committee of the Board of Directors approved a milestone payment in the amount of $0.3 million in connection with the Executive Incentive Program for Mr. Aminov tied to the completion of drug development and financing milestones as outlined in the Executive Incentive Program plan.
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Alan Weichselbaum
On May 15, 2025, the Company entered into an Employment Agreement (the “Employment Agreement”) with Mr. Weichselbaum to serve as chief financial officer beginning on May 19, 2025. Under the Employment Agreement, Mr. Weichselbaum will receive an annual salary of $60,000
Michelle Yanez
On March 25, 2024, the Compensation Committee of the Board of Directors approved an increase in Ms. Yanez’s base salary of $0.06 million, bringing her annual base salary to $0.23 million. Ms. Yanez and the Company signed a Separation Agreement on May 20, 2025, effective June 18, 2025.
Grants of Plan-Based Awards in 2025
|
Estimated Future Payouts Under Non-Equity Incentive Plan Awards |
Estimated Future Payouts Under Equity Incentive Plan Awards |
All Other Stock Awards: Number of Shares of Stocks or |
All Other Option Awards: Number of Securities Underlying |
Exercise or Base Price of Option |
Closing stock price on Award |
Grant Date Fair Value of Stock and |
||||||||||||||||||||||||||||||||||||||||||
| Name | Grant Date |
Threshold ($) |
Target ($) |
Maximum ($) |
Threshold (#) |
Target (#) |
Maximum (#) |
Units (#) |
Options (#) |
Awards ($/Sh) |
date ($/Sh) |
Option Awards |
||||||||||||||||||||||||||||||||||||
| Erez | 8/15/2025 | 62,500 | (1) | $ | 1.50 | $ | 93,750 | |||||||||||||||||||||||||||||||||||||||||
| Aminov, | 12/16/2025 | 62,500 | (1) | $ | 1.45 | $ | 90,625 | |||||||||||||||||||||||||||||||||||||||||
| CEO | 12/16/2025 | 3,155,170 | (2) | $ | 1.45 | $ | 1.45 | $ | 4,419,117 | |||||||||||||||||||||||||||||||||||||||
|
Alan Weichselbaum, CFO(4) |
5/13/2025 | 75,000 | (3) | $ | 1.16 | $ | 1.16 | $ | 87,300 | |||||||||||||||||||||||||||||||||||||||
| (1) | The stock awards disclosed in this item consist of performance-based and market-based Restricted Stock Units (RSU’s), as issued under our 2022 Omnibus Incentive Plan, which vest based on the following criteria subject to Board approval and determination: 62,500 RSUs to vest upon the Company’s achievement of a market capitalization of $25 million; 62,500 RSUs to vest upon the Company’s achievement of a market capitalization of $50 million; 62,500 RSUs to vest upon the Company’s achievement of a market capitalization of $100 million; 62,500 RSUs to vest upon the Company’s achievement of a market capitalization of $150 million; 83,500 RSUs to vest upon the Company’s submission of an IND for MIRA-55; 83,500 RSUs to vest upon the Company’s initiation of a Phase 1 trial for Ketamir-2, and 83,500 RSUs to vest upon the Company’s initiation of a Phase 2a trial for Ketamir-2. Following the Board’s and Committee’s determinations that the $25 million market capitalization threshold was achieved on July 18, 2025 and the $50 million market capitalization threshold was achieved on December 16, 2025, the Company issued to Erez Aminov, on the respective grant dates of August 15, 2025 and December 12, 2025, $50,000 in cash and 62,500 fully vested restricted stock units for each grant, with the restricted stock units having aggregate fair market values of $93,750 and $90,625, respectively. |
| (2) | The stock awards disclosed in this item consist of options, as issued under our 2022 Omnibus Incentive Plan, which vested immediately on grant date. |
| (3) | On May 13, 2025, Alan Weichselbaum, was granted an option award of 75,000 options valued at $87,300. The stock awards disclosed in this item consist of options, as issued under our 2022 Omnibus Incentive Plan, which 50% six months after grant date and 50% on the first anniversary of grant date. |
Outstanding equity awards
The following table summarizes outstanding unexercised options held by each of our named executive officers, as of December 31, 2025.
| OPTION AWARDS | STOCK AWARDS | |||||||||||||||||||||||||||||||||
| Name | Number of Securities Underlying Unexercised Options (#) Exercisable | Number of Securities Underlying Unexercised Options (#) Unexercisable | Equity Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Options (#) | Options Exercise Prices ($) | Option Expiration Date | Number of Shares or Units of Stock That Have Not Vested (#) | Market Value of Shares or Units of Stock That Have Not Vested ($) | Equity Incentive Plan Awards: Number of Unearned Shares, Units or Other Rights That Have Not Vested (#) | Equity Incentive Plan Awards: Market or Payout Value of Unearned Shares, Units or Other Rights That Have Not vested (#) | |||||||||||||||||||||||||
| Erez Aminov | 150,000 | - | - | $ | 1.38 | 8/16/33 | - | - | - | - | ||||||||||||||||||||||||
| 15,384 | - | $ | 1.38 | 8/16/33 | - | - | - | |||||||||||||||||||||||||||
| 134,616 | - | - | $ | 1.38 | 4/27/33 | - | - | - | - | |||||||||||||||||||||||||
| 65,405 | - | - | $ | 1.16 | 3/25/34 | - | - | - | - | |||||||||||||||||||||||||
| 2,000,000 | - | - | $ | 1.19 | 12/6/34 | - | - | - | - | |||||||||||||||||||||||||
| 68,960 | - | - | $ | 1.45 | 12/16/35 | |||||||||||||||||||||||||||||
| 3,155,170 | - | - | $ | 1.45 | 12/16/35 | - | - | - | - | |||||||||||||||||||||||||
- | - | - | - | |||||||||||||||||||||||||||||||
| Alan | ||||||||||||||||||||||||||||||||||
| Weichselbaum | 37,500 | 37,500 | - | $ | 1.18 | 5/13/35 | - | - | - | - | ||||||||||||||||||||||||
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Option Exercises and Stock Vested
On July 15, 2025, Michelle Yanez, the Company’s former Chief Financial Officer, exercised options to purchase 126,061 shares of the Company’s common stock. The Company received $151,023 in net proceeds from this transaction. On September 12, 2025, Michelle Yanez exercised options to purchase 98,939 shares of the Company’s common stock. The Company received $117,019 in net proceeds from this transaction. On September 22, 2025, a former company employee exercised options to purchase 25,000 shares of the Company’s common stock. The Company received $29,750 in net proceeds from this transaction.
On October 16, 2025, Erez Aminov, the Company’s Chairman and Chief Executive Officer, exercised options to purchase 613,595 shares of the Company’s common stock. The Company received $590,490 in net proceeds from this transaction.
In the year ended December 31, 2025, 6,018,075 options vested with a fair market value of $7,631,318.
2022 Omnibus Incentive Plan
Our board of directors has adopted, and our stockholders have approved, our 2022 Omnibus Incentive Plan, or the 2022 Omnibus Plan. The 2022 Omnibus Plan authorizes the grant of incentive stock options, within the meaning of Section 422 of the Internal Revenue Code, to our employees and any of our parent and subsidiary corporations’ employees, and the grant of nonstatutory stock options, restricted stock, restricted stock units, stock appreciation rights, performance units and performance shares to our employees, directors, and consultants and any of our future subsidiary corporations’ employees and consultants. The following is a summary of certain terms and conditions of the 2022 Omnibus Plan. This summary is qualified in its entirety by reference to the 2022 Omnibus Plan attached as an exhibit to this Report.
Administration
The 2022 Omnibus Plan is administered by our board of directors or our compensation committee, or any other committee or subcommittee or one or more of our officers to whom authority has been delegated (collectively, the “Administrator”). The Administrator has the authority to interpret the 2022 Omnibus Plan and award agreements entered into with respect to the 2022 Omnibus Plan; to make, change and rescind rules and regulations relating to the 2022 Omnibus Plan; to make changes to, or reconcile any inconsistency in, the 2022 Omnibus Plan or any award agreement covering an award; and to take any other actions needed to administer the 2022 Omnibus Plan.
Eligibility
The Administrator may designate any of the following as a participant under the 2022 Omnibus Plan: any officer or employee, or individuals engaged to become an officer or employee, of our company or our affiliates; and consultants of our company or our affiliates, and our directors, including our non-employee directors.
Types of Awards
The 2022 Omnibus Plan permits the Administrator to grant stock options, stock appreciation rights (“SARs”), performance shares, performance units, shares of common stock, restricted stock, restricted stock units (“RSUs”), cash incentive awards, dividend equivalent units, or any other type of award permitted under the 2022 Omnibus Plan. The Administrator may grant any type of award to any participant it selects, but only our employees or our subsidiaries’ employees may receive grants of incentive stock options within the meaning of Section 422 of the Internal Revenue Code. Awards may be granted alone or in addition to, in tandem with, or (subject to the repricing prohibition described below) in substitution for any other award (or any other award granted under another plan of our company or any affiliate, including the plan of an acquired entity).
Shares Reserved Under the 2022 Omnibus Incentive Plan
The 2022 Omnibus Plan provides that 8,000,000 shares of our common stock are reserved for issuance under the 2022 Omnibus Plan, all of which may be issued pursuant to the exercise of incentive stock options. The number of shares available for issuance under our 2022 Omnibus Plan will also include an annual increase on the first day of each fiscal year equal to the lesser of:
| ● | 500,000 shares; |
| ● | 5.0% of the outstanding shares of all class of our common stock as of the last day of the immediately preceding fiscal year; or |
| ● | such other amount as our board of directors may determine. |
The number of shares reserved for issuance under the 2022 Omnibus Plan will be reduced on the date of the grant of any award by the maximum number of shares, if any, with respect to which such award is granted. However, an award that may be settled solely in cash will not deplete the 2022 Omnibus Plan’s share reserve at the time the award is granted. If (a) an award expires, is canceled, or terminates without issuance of shares or is settled in cash, (b) the Administrator determines that the shares granted under an award will not be issuable because the conditions for issuance will not be satisfied, (c) shares are forfeited under an award, (d) shares are issued under any award and we reacquire them pursuant to our reserved rights upon the issuance of the shares, (e) shares are tendered or withheld in payment of the exercise price of an option or as a result of the net settlement of outstanding stock appreciation rights or (f) shares are tendered or withheld to satisfy federal, state or local tax withholding obligations, then those shares are added back to the reserve and may again be used for new awards under the 2022 Omnibus Plan. However, shares added back to the reserve pursuant to clauses (d), (e) or (f) in the preceding sentence may not be issued pursuant to incentive stock options.
Options
The Administrator may grant stock options and determine all terms and conditions of each stock option, which include the number of stock options granted, whether a stock option is to be an incentive stock option or non-qualified stock option, and the grant date for the stock option. However, the exercise price per share of common stock may never be less than the fair market value of a share of common stock on the date of grant and the expiration date may not be later than 10 years after the date of grant. Stock options will be exercisable and vest at such times and be subject to such restrictions and conditions as are determined by the Administrator, including with respect to the manner of payment of the exercise price of such stock options.
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Stock Appreciation Rights
The Administrator may grant SARs, which represent the right of a participant to receive cash in an amount, or common stock with a fair market value, equal to the appreciation of the fair market value of a share of common stock during a specified period of time. The 2022 Omnibus Plan provides that the Administrator will determine all terms and conditions of each SAR, including, among other things: (a) whether the SAR is granted independently of a stock option or relates to a stock option, (b) the grant price, which may never be less than the fair market value of our common stock as determined on the date of grant, (c) a term that must be no later than 10 years after the date of grant, and (d) whether the SAR will settle in cash, common stock or a combination of the two.
Performance and Stock Awards
The Administrator may grant awards of shares of common stock, restricted stock, RSUs, performance shares or performance units. Restricted stock means shares of common stock that are subject to a risk of forfeiture or restrictions on transfer, which may lapse upon the achievement or partial achievement of performance goals (as described below) or upon the completion of a period of service. An RSU grants the participant the right to receive cash or shares of common stock the value of which is equal to the fair market value of one share of common stock, to the extent performance goals are achieved or upon the completion of a period of service. Performance shares give the participant the right to receive shares of common stock to the extent performance goals are achieved. Performance units give the participant the right to receive cash or shares of common stock valued in relation to a unit that has a designated dollar value or the value of which is equal to the fair market value of one or more shares of common stock, to the extent performance goals are achieved.
The Administrator will determine all terms and conditions of the awards including (a) whether performance goals must be achieved for the participant to realize any portion of the benefit provided under the award, (b) the length of the vesting or performance period and, if different, the date that payment of the benefit will be made, (c) with respect to performance units, whether to measure the value of each unit in relation to a designated dollar value or the fair market value of one or more shares of common stock, and (d) with respect to performance shares, performance units, and RSUs, whether the awards will settle in cash, in shares of common stock (including restricted stock), or in a combination of the two.
Cash Incentive Awards
The Administrator may grant cash incentive awards. An incentive award is the right to receive a cash payment to the extent one or more performance goals are achieved. The Administrator will determine all terms and conditions of a cash incentive award, including, but not limited to, the performance goals (described below), the performance period, the potential amount payable, and the timing of payment. While the 2022 Omnibus Plan permits cash incentive
Performance Goals
For purposes of the 2022 Omnibus Plan, the Administrator may establish objective or subjective performance goals which may apply to any performance award. Such performance goals may include, but are not limited to, one or more of the following measures with respect to our company or any one or more of our subsidiaries, affiliates, or other business units: net sales; cost of sales; gross income; gross revenue; revenue; operating income; earnings before taxes; earnings before interest and taxes; earnings before interest, taxes, depreciation and amortization; earnings before interest, taxes, depreciation, amortization and exception items; income from continuing operations; net income; earnings per share; diluted earnings per share; total stockholder return; fair market value of a share of common stock; cash flow; net cash provided by operating activities; net cash provided by operating activities less net cash used in investing activities; ratio of debt to debt plus equity; return on stockholder equity; return on invested capital; return on average total capital employed; return on net capital employed; return on assets; return on net assets employed before interest and taxes; operating working capital; average accounts receivable (calculated by taking the average of accounts receivable at the end of each month); average inventories (calculated by taking the average of inventories at the end of each month); economic value added; succession planning; manufacturing return on assets; manufacturing margin; and customer satisfaction. Performance goals may also relate to a participant’s individual performance. The Administrator reserves the right to adjust any performance goals or modify the manner of measuring or evaluating a performance goal.
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Dividend Equivalent Units
The Administrator may grant dividend equivalent units. A dividend equivalent unit gives the participant the right to receive a payment, in cash or shares of common stock, equal to the cash dividends or other distributions that we pay with respect to a share of common stock. We determine all terms and conditions of a dividend equivalent unit award, except that dividend equivalent units may not be granted in connection with a stock option or SAR, and dividend equivalent unit awards granted in connection with another award cannot provide for payment until the date such award vests or is earned, as applicable.
Other Stock-Based Awards
The Administrator may grant to any participant shares of unrestricted stock as a replacement for other compensation to which such participant is entitled, such as in payment of director fees, in lieu of cash compensation, in exchange for cancellation of a compensation right or as a bonus.
Transferability
Awards are not transferable, including to any financial institution, other than by will or the laws of descent and distribution, unless the Administrator allows a participant to (a) designate in writing a beneficiary to exercise the award or receive payment under the award after the participant’s death, (b) transfer an award to a former spouse as required by a domestic relations order incident to a divorce, or (c) transfer an award without receiving any consideration.
Adjustments
If (a) we are involved in a merger or other transaction in which our shares of common stock are changed or exchanged; (b) we subdivide or combine shares of common stock or declare a dividend payable in shares of common stock, other securities, or other property (other than stock purchase rights issued pursuant to a stockholder rights agreement); (c) we effect a cash dividend that exceeds 10% of the fair market value of a share of common stock or any other dividend or distribution in the form of cash or a repurchase of shares of common stock that our board of directors determines is special or extraordinary, or that is in connection with a recapitalization or reorganization; or (d) any other event occurs that in the Administrator’s judgment requires an adjustment to prevent dilution or enlargement of the benefits intended to be made available under the 2022 Omnibus Plan, then the Administrator will, in a manner it deems equitable, adjust any or all of (1) the number and type of shares subject to the 2022 Omnibus Plan and which may, after the event, be made the subject of awards; (2) the number and type of shares of common stock subject to outstanding awards; (3) the grant, purchase, or exercise price with respect to any award; and (4) the performance goals of an award. In any such case, the Administrator may also provide for a cash payment to the holder of an outstanding award in exchange for the cancellation of all or a portion of the award, subject to the terms of the 2022 Omnibus Plan.
The Administrator may, in connection with any merger, consolidation, acquisition of property or stock, or reorganization, authorize the issuance or assumption of awards upon terms and conditions we deem appropriate without affecting the number of shares of common stock otherwise reserved or available under the 2022 Omnibus Plan.
Change of Control
Upon a change of control (as defined in the 2022 Omnibus Plan), the successor or surviving corporation may agree to assume some or all outstanding awards or replace them with the same type of award with similar terms and conditions, without the consent of any participant, subject to the following requirements:
| ● | Each award that is assumed must be appropriately adjusted, immediately after such change of control, to apply to the number and class of securities that would have been issuable to a participant upon the consummation of such change of control had the award been exercised, vested, or earned immediately prior to such change of control, and other appropriate adjustment to the terms and conditions of the award may be made. |
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| ● | If the securities to which the awards relate after the change of control are not listed and traded on a national securities exchange, then (a) each participant must be provided the option to elect to receive, in lieu of the issuance of such securities, cash in an amount equal to the fair value of the securities that would have otherwise been issued, and (b) no reduction may be taken to reflect a discount for lack of marketability, minority, or any similar consideration, for purposes of determining the fair value of such securities. |
| ● | If a participant is terminated from employment without cause, or due to death or disability, or the participant resigns employment for good reason (as defined in any award or other agreement between the participant and our company or an affiliate) within two years following the change of control, then upon such termination, all of the participant’s awards in effect on the date of such termination will vest in full or be deemed earned in full. |
If the purchaser, successor, or surviving entity does not assume the awards or issue replacement awards, then immediately prior to the change of control date, unless the Administrator otherwise determines:
| ● | Each stock option or SAR then held by a participant will become immediately and fully vested, and all stock options and SARs will be cancelled on the change of control date in exchange for a cash payment equal to the excess of the change of control price of the shares of common stock over the purchase or grant price of such shares under the award. |
| ● | Unvested restricted stock and RSUs (that are not performance awards) will vest in full. |
| ● | All performance shares, performance units and cash incentive awards for which the performance period has expired will be paid based on actual performance, and all such awards for which the performance period has not expired will be cancelled in exchange for a cash payment equal to the amount that would have been due under such awards, valued assuming achievement of target performance goals at the time of the change of control, prorated based on the number of full months elapsed in the performance period. |
| ● | All unvested dividend equivalent units will vest (to the same extent as the award granted in tandem with such units) and be paid. |
| ● | All other unvested awards will vest and any amounts payable will be paid in cash. |
Term of Plan
Unless earlier terminated by our board of directors, the 2022 Omnibus Plan will terminate on, and no further awards may be granted, after the tenth (10th) anniversary of its effective date.
Termination and Amendment of Plan
Our board of directors or the Administrator may amend, alter, suspend, discontinue, or terminate the 2022 Omnibus Plan at any time, subject to the following limitations:
| ● | Our board of directors must approve any amendment to the 2022 Omnibus Plan if we determine such approval is required by prior action of our board of directors, applicable corporate law, or any other applicable law; |
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| ● | Stockholders must approve any amendment to the 2022 Omnibus Plan, which may include an amendment to materially increase the number of shares reserved under the 2022 Omnibus Plan, if we determine that such approval is required by Section 16 of the Exchange Act, the Code, the listing requirements of any principal securities exchange or market on which the shares are then traded, or any other applicable law; and |
| ● | Stockholders must approve any amendment to the 2022 Omnibus Plan that would diminish the protections afforded by the participant award limits or repricing and backdating prohibitions. |
Amendment, Modification, Cancellation and Disgorgement of Awards
Subject to the requirements of the 2022 Omnibus Plan, the Administrator may modify or amend any award or waive any restrictions or conditions applicable to any award or the exercise of the award, or amend, modify, or cancel any terms and conditions applicable to any award, in each case, by mutual agreement of the Administrator and the participant or any other person that may have an interest in the award, so long as any such action does not increase the number of shares of common stock issuable under the 2022 Omnibus Plan.
We do not need to obtain participant (or other interested party) consent for any such action (a) that is permitted pursuant to the adjustment provisions of the 2022 Omnibus Plan; (b) to the extent we deem the action necessary to comply with any applicable law or the listing requirements of any principal securities exchange or market on which our common stock is then traded; (c) to the extent we deem the action is necessary to preserve favorable accounting or tax treatment of any award for us; or (d) to the extent we determine that such action does not materially and adversely affect the value of an award or that such action is in the best interest of the affected participant or any other person as may then have an interest in the award.
The Administrator can cause a participant to forfeit any award, and require the participant to disgorge any gains attributable to the award, if the participant engages in any action constituting, as determined by the Administrator in its discretion, cause for termination, or a breach of a material company policy, any award agreement or any other agreement between the participant and us or one of our affiliates concerning noncompetition, nonsolicitation, confidentiality, trade secrets, intellectual property, nondisparagement or similar obligations.
Any awards granted under the 2022 Omnibus Plan, and any shares of common stock issued or cash paid under an award, will be subject to recoupment our Compensation Recovery Policy (as described below), or any recoupment or similar requirement otherwise made applicable by law, regulation or listing standards to us, or that may be provided for in any cash or equity award granted by us.
Compensation of Directors
No compensation was paid to our Board members during the year ended December 31, 2025.
Compensation Recovery Policy
On October 2, 2023, our Board of Directors adopted a policy (commonly known as a “clawback” policy) which provides for the recovery of erroneously awarded incentive compensation to certain of our officers in the event that we are required to prepare an accounting restatement due to material noncompliance by us with any financial reporting requirements under the federal securities laws. This policy is designed to comply with Section 10D of the Securities Exchange Act of 1934, as amended, related rules and the listing standards of Nasdaq Stock Market or any other securities exchange on which our shares are listed in the future. The policy is administered by our Board of Directors or, if so designated by the Board of Directors, the Compensation Committee. Any determinations made by the Board shall be final and binding on all affected individuals.
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The individuals covered by this policy (the “Covered Officers”) are any current or former employee who is or was identified as our president, principal financial officer, principal accounting officer (or if there is no such accounting officer, the controller), any vice-president in charge of a principal business unit, division, or function (such as sales, administration, or finance), any other officer who performs a significant policy-making function, or any other person (including any executive officer of our subsidiaries or affiliates) who performs similar significant policy-making functions for us.
The policy covers our recoupment of “Incentive-Based Compensation” (as defined in the policy) received by a person after beginning service as a Covered Executive and who served as a Covered Officer at any time during the performance period for that Incentive Compensation. In the event we are required to prepare an accounting restatement, the policy requires us to recover, reasonably promptly, any excess incentive compensation (as determined by our Board of Directors or Compensation Committee) received by any Covered Officer during the three completed fiscal years immediately preceding the date on which we are required to prepare such accounting restatement. The foregoing description of our Compensation Recovery Policy does not purport to be complete and is qualified in its entirety by the terms and conditions of such policy, a copy of which is filed as an exhibit to this Report and is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The following table sets forth, as of the date of this Report, the ownership of our securities by: (i) each of our directors, (ii) all persons who, to our knowledge, are the beneficial owners of more than 5% of the outstanding shares of common stock, (iii) each of the executive officers, and (iv) all of our directors and executive officers, as a group. Each person named in this table has sole investment power and sole voting power with respect to the shares of common stock set forth opposite such person’s name, except as otherwise indicated.
| Name and Address of Beneficial Owner | Amount and Nature of Beneficial Ownership | Percentage of Class as of March 28, 2025 | ||||||
| Directors and Executive Officers (1) | ||||||||
| Erez Aminov | 9,113,241 | 21,73 | % | |||||
| Alan Weichselbaum | 75,000 | * | ||||||
| Matthew Whalen | 25,000 | * | ||||||
| Matthew Del Giudice | 75,000 | * | ||||||
| Denil Nanji Shekhat | 133,333 | * | ||||||
| Edward MacPherson | 75,000 | * | ||||||
| All current directors and officers as a group (6 persons) (2) | 9,496,574 | 22.64 | % | |||||
| 5% Stockholders | ||||||||
| Brian McNulty(3) | 5,029,317 | 29.14 | % | |||||
| * | Represents beneficial ownership of less than 1% |
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| (1) | Unless otherwise denoted, the address of each noted person is 1200 Brickell Avenue, Suite 1950 #1183, Miami, Florida 33131. |
| (2) | Includes both founders shares and shares subject to options granted under our 2022 Omnibus Plan that are exercisable as of the Beneficial Ownership Date or within 60 days of the Beneficial Ownership Date held as follows: Mr. Aminov, 9,113,241 shares and Mr. Weichselbaum, 75,000 shares, Dr. Del Guidice, 25,000 shares, Dr. Shekhat, 133,333 shares, Mr. MacPherson, 75,000 shares, and all current officers and directors as a group, 9,496,574 shares. Excludes shares subject to options granted under our 2022 Omnibus Plan that are not exercisable within 60 days of the Beneficial Ownership Date. |
| (3) |
Includes (i) 10,000 shares held directly by Mr. McNulty, (ii) 2,540,270 shares held by the Bay Shore Trust, (iii) 779,047 shares held by the Celeste J Williams Lifetime QTIP Trust, (iv) 1,000,000 shares issuable pursuant to warrants held by the Bay Shore Trust that are immediately exercisable, and (v) 700,000 shares issuable pursuant to warrants held by MIRALOGX LLC, that are immediately exercisable. As trustee of the Bay Shore Trust and the Celeste J Williams Lifetime QTIP Trust, Mr. McNulty has sole voting and dispositive power over the shares held by each trust, and, as a result is deemed to have beneficial ownership (as determined under Section 13(d) of the Exchange Act) of the securities held by the trusts. The address for MIRALOGX LLC and the Bay Shore Trust is 900 West Platt Street, Suite 200, Tampa, Florida, 33606. |
DELINQUENT SECTION 16(A) REPORTS
Section 16(a) of the Exchange Act requires directors and executive officers, and persons who own more than 10% of the Company’s common stock, to report to the SEC their initial ownership of the Company’s common stock and any subsequent changes in that ownership. Specific due dates for these reports have been established by the SEC and we are required to disclose in this Annual Report on Form 10-K any late filings or failures to file.
Mr. Erez Aminov, CEO and director of the Company, did not report several grants and vesting of options and RSUs of the Company during the 2025 fiscal year. Mr. Aminov subsequently filed on February 17, 2026 a Form 5 with the SEC reporting such issuances.
Other than the above, based solely on review of the copies of such reports furnished to us and written representations from reporting persons that no other reports were required during the fiscal year ended December 31, 2025, we believe that, during the 2025 fiscal year, all of the Company’s directors and executive officers complied with all Section 16(a) filing requirements applicable to them.
Securities Authorized for Issuance Under Equity Compensation Plans
The following table indicates shares of common stock authorized for issuance under our 2022 Omnibus Plan as of December 31, 2025:
| Plan category | Number of securities to be issued upon exercise of outstanding options and RSU | Weighted- average exercise price of outstanding options and RSU | Number of securities remaining available for future issuance | |||||||||
| Equity compensation plans approved by security holders | 6,072,242 | $ | 1.34 | 1,220,102 | ||||||||
| Equity compensation plans not approved by security holders | - | - | - | |||||||||
| Total | 6,072,242 | $ | 1.34 | 1,220,102 | ||||||||
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The following is a description of transactions within the last two years to which we have been a party, in which the amount involved exceeded or will exceed $120,000, and in which any of our executive officers, directors or holders of more than 5% of our voting securities, or an immediate family member thereof, had or will have a direct or indirect material interest. We believe the terms obtained or consideration that we paid or received, as applicable, in connection with the transactions described below were comparable to terms available or amounts that would be paid or received, as applicable, in arm’s-length transactions with unrelated third parties.
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Line of Credit and Promissory Note with the Bay Shore Trust
On April 28, 2023, we entered into the Bay Shore Note with the Bay Shore Trust, under which we have the right to borrow up to an aggregate of $5,000,000 from the Bay Shore Trust at any time up to the second anniversary of the issuance of the Bay Shore Note or, if earlier, upon the completion of our initial public offering. Our right to borrow funds under the Bay Shore Note is subject to the absence of a material adverse change in our assets, operations, or prospects. The Bay Share Note, together with accrued interest, will become due and payable on the second anniversary of the issuance of the note, provided that it may be prepaid at any time without penalty. The Bay Shore Note will accrue interest at a rate equal 7% per annum, simple interest, during the first year that the note is outstanding and 10% per annum, simple interest, thereafter. The Bay Shore Note is unsecured. As of June 30, 2023, the Bay Shore Note had an outstanding principal balance of $1.8 million and accrued and unpaid interest of $0.04 million. Under the Bay Shore Trust Conversion Agreement, the Bay Shore Trust agreed to convert, upon the completion of our initial public offering, $1,100,190 of the outstanding principal balance of the Bay Shore Note into shares of our common stock at a conversion price equal to our initial public offering price, which resulted in the issuance of 157,170 shares to the Bay Shore Trust upon the completion of our initial public offering. The note was paid off as of December 31, 2023.
In consideration of the loan facility provided by the Bay Shore Trust, we issued to the Bay Shore Trust a common stock purchase warrant on April 28, 2023 giving the Bay Shore Trust the right to purchase up to 1,000,000 shares of common stock at an exercise price of $5.00 per share, which warrant will expire five years after the date of grant. Pursuant to a registration rights agreement, we have granted to Bay Shore Trust the right to require us, at any time after one year following our initial public offering, to register for resale the shares issuable upon the exercise of the warrant, with such registration rights being in the form of demand and “piggyback” registration rights that are subject to customary limitations and restrictions. Upon issuance, the warrant met the criteria to be classified as equity based on an analysis under Accounting Standards Codification (480) ASC 480, “Distinguishing Liabilities from Equity” and was measured at fair value, resulting in an initial fair value of approximately $3.5 million upon issuance of the warrant using Black-Scholes valuation techniques.
Transactions with MIRALOGX LLC
Since January 1, 2023, MIRALOGX has advanced funds on behalf of Bay Shore Trust to our company in order to fund operating activities. The total amount advanced and outstanding from MIRALOGX was $1.6 million immediately prior to being consolidated into the Bay Shore Note on June 30, 2023, and such amounts became a part of the outstanding balance of the Bay Shore Note as of June 30, 2023 and were payable under the terms of the Bay Shore Note as discussed above.
We are also a party to an Agreement for Shared Lease Costs, dated April 1, 2023, with MIRALOGX under which we have agreed to pay our pro rata share of the operating usage costs owing by MIRALOGX under an aircraft lease agreement between MIRALOGX and Supera Aviation I LLC (“Supera Aviation”) based on our usage of the leased aircraft each month. No amounts are payable by us under this agreement unless and to the extent we choose to utilize the leased aircraft. As such, we discontinued the use of the aircraft in March 2023. Prior to entering into this agreement, we were a party to an aircraft lease agreement with Supera Aviation from April 20, 2021, through March 31, 2023. We paid Supera Aviation an aggregate of $0.5 million during the first quarter of 2023 and $1.7 million in 2022. Supera Aviation is a company owned by Starwood Trust.
On November 15, 2023, we entered into an exclusive license agreement in with MIRALOGX to develop and commercialize a drug product containing 2-(2-chlorophenyl)-2-(methylamino) cyclopentan-1-one (sometimes referred to by the Parties as “M209” or “KETAMIR-2”) as an active agent in North America. The exclusive license in the license agreement includes our right to sublicense the licensed intellectual property. Pursuant to the terms of the license agreement, and subject to the conditions set forth therein, we paid MIRALOGX a one-time, nonrefundable payment of $100,000 upon the signing of the Agreement and will be obligated to pay quarterly royalty payments on sales of the Product in the Territory of 8% of net sales and 8% of other revenue (such as milestone or sublicense payments) from licensed products. Also, in consideration of License Agreement, we issued to MIRALOGX a common stock purchase warrant to purchase up to 700,000 shares of our common stock. The MIRALOGX Warrants are exercisable, in whole or in part, any time prior to November 15, 2028, at a cash exercise price of $2.00 per share.
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On November 15, 2023, we entered into a promissory note and loan agreement with MIRALOGX. Pursuant to the loan agreement, we may borrow up to $3.0 million from MIRALOGX to fund the development of licensed products under the license agreement. Together with any advance request, we will deliver to the Lender a budget for the requested advance. The budget may only include costs directly associated with preparing an IND application for KETAMIR-2, exclusive of personnel costs. Any advances made by the Lender to us pursuant to this note may be repaid by us (together with any and all interest accrued thereon) at any time without penalty or premium in accordance with the terms hereof. Amounts repaid hereunder may not be reborrowed. The loan agreement has a one-year term, and all outstanding principal and accrued but unpaid interest must be repaid in full on November 15, 2024. Interest on the amounts borrowed under the loan agreement accrues at an annual fixed rate of 8%. We may prepay all or a portion of the outstanding principal and accrued unpaid interest under the loan agreement at any time without a prepayment fee. The Company did not borrow any funds from the MIRALOGX loan during the year ended December 31, 2025 or December 31, 2024 and the Loan Agreement expired on November 15, 2024.
Consulting and Employment Agreements with Dr. Chris Chapman
On April 1, 2022, we entered into a Consulting Agreement with Dr. Chapman pursuant to which he provided regulatory and drug development consulting services to the Company on an as-requested basis. Pursuant to the Consulting Agreement, he was to be paid a one-time fee of $100,000 upon the completion of our initial public offering (of which $50,000 was prepaid in in the first quarter of 2022) plus a monthly fee of $20,000 thereafter. The monthly fee was to begin upon the completion of our initial public offering. He was also reimbursed for reasonable out-of-pocket expenses incurred in connection with his duties under the Consulting Agreement. The agreement had a term of one year with an automatic one-year extension, provided that either party could terminate the agreement without cause upon 30-days prior written notice.
In his capacity as a consultant, Dr. Chapman was also granted on June 15, 2022, an option to purchase up to 200,000 shares of our common stock at an exercise price of $5.00 per share. Upon Dr. Chapman becoming Executive Chairman, received additional compensation in that capacity, and his employment agreement replaced his Consulting Agreement. See “Executive Compensation” above. Dr. Chapman resigned his positions with our company on March 9, 2024.
Review and Approval of Related Party Transactions
Our board of directors has adopted a written policy regarding the review and approval of related party transactions. Our audit committee charter provides that the audit committee shall review and approve or disapprove any related party transactions, which are transactions between us and related persons in which the aggregate amount involved exceeds or may be expected to exceed the lessor of $120,000 or one percent of the average of our total assets at year end for the last two completed fiscal years and in which a related person has or will have a direct or indirect material interest. Our policy regarding transactions between us and related persons provides that a related person is defined as a director, executive officer, nominee for director or greater than 5% beneficial owner of our common stock, in each case since the beginning of the most recently completed year, and any of their immediate family members.
Certain of the foregoing disclosures are summaries of certain provisions of our related party agreements and are qualified in their entirety by reference to all of the provisions of such agreements. Because these descriptions are only summaries of the applicable agreements, they do not necessarily contain all of the information that you may find useful. Copies of certain of the agreements have been filed as exhibits to this Report and are available electronically on the website of the SEC at www.sec.gov.
As a matter of corporate governance policy, we have not and will not make loans to officers or loan guarantees available to “promoters” as that term is commonly understood by the SEC and state securities authorities.
All future transactions between us and our officers, directors or five percent stockholders, and respective affiliates will be on terms no less favorable than could be obtained from unaffiliated third parties and will be approved by a majority of our independent directors who do not have an interest in the transactions and who had access, at our expense, to our legal counsel or independent legal counsel.
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Item 14. Principal Accountant Fees and Services.
Audit Fees.
Company appointed Salberg & Company P.A (“Salberg”) effective December 19, 2024. Salberg served as our independent auditor for the years ended December 31, 2025 and December 31, 2024. The Company also incurred certain fees during the years ended December 31, 2024 for audit services rendered by Cherry Bekaert LLP before appointment of Salberg.
| For the year ended December 31 | ||||||||
| 2025 | 2024 | |||||||
| Audit fees, Salberg and Company (1) | $ | 87,000 | $ | 51,000 | ||||
| Audit fees, Cherry Bekaert LLP (1) | — | 80,000 | ||||||
| Audit-related fees, Salberg (2) | 28,000 | — | ||||||
| Audit-related fees, Cherry Bekaert LLP (2) | — | 50,000 | ||||||
| Tax fees(3) | — | — | ||||||
| All other fees(4) | — | — | ||||||
| Total fees | $ | 137,000 | $ | 181,000 | ||||
| (1) | Audit fees consist of fees for professional services rendered in connection with the audit of our annual consolidated financial statements, the review of the financial statements included in quarterly reports. | |
| (2) | Audit-related fees billed in 2025 and 2024 consist of fees for professional services rendered in connection with review and update procedures associated with registration statements, comfort letters and other SEC filings. | |
| (3) | There were no tax-related fees billed in 2025 and 2024. | |
| (4) | There were no other fees billed in 2025 and 2024. |
The Audit Committee of our board of directors has established its pre-approval policies and procedures, pursuant to which the Audit Committee approved the foregoing audit and non-audit services provided by Cherry Bekaert LLP and Salberg & Company P.A in 2025 . Consistent with the Audit Committee’s responsibility for engaging our independent auditors, all audit and permitted non-audit services require pre-approval by the Audit Committee. The full Audit Committee approves proposed services and fee estimates for these services. The Audit Committee chairperson has been designated by the Audit Committee to approve any audit-related services arising during the year that were not pre-approved by the Audit Committee. Any non-audit service must be approved by the full Audit Committee. Services approved by the Audit Committee chairperson are communicated to the full Audit Committee at its next regular meeting and the Audit Committee reviews services and fees for the fiscal year at each such meeting. Pursuant to these procedures, the Audit Committee approved the foregoing services provided by Cherry Bekaert LLP and Salberg & Company P.A.
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PART IV
Item 15. Exhibits, Financial Statement Schedules.
The information called for by this Item is incorporated herein by reference to the Exhibit Index in this Form 10-K.
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| + | Denotes management contract or compensatory plan or arrangement. | |
| * | Filed herewith | |
| ** | Furnished herewith | |
| # | A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request. |
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SIGNATURES
In accordance with Section 13 or 15(d) of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| MIRA PHARMACEUTICALS, INC. | ||
| Date: March 31, 2026 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |
| (Principal Executive Officer) | ||
| By: | /s/ Alan Weichselbaum | |
| Name: | Alan Weichselbaum | |
| Title: | Chief Financial Officer | |
| (Principal Financial Officer) | ||
In accordance with the Exchange Act, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
| Person | Capacity | Date | ||
| /s/ Erez Aminov | Chief Executive Officer and Chairman | March 31, 2026 | ||
| Erez Aminov | ||||
| /s/ Alan Weichselbaum | Chief Financial Officer | March 31, 2026 | ||
| Alan Weichselbaum | ||||
| /s/ Matthew Whalen | Director | March 31, 2026 | ||
| Matthew Whalen | ||||
| /s/ Matthew Del Giudice | Director | March 31, 2026 | ||
| Matthew Del Giudice | ||||
| /s/ Denil Shekhat | Director | March 31, 2026 | ||
| Denil Shekhat | ||||
| /s/ Edward MacPherson | Director | March 31, 2026 | ||
| Edward MacPherson |
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